By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The GI-Drug Discovery Unit at Takeda is a team of experienced, innovative and collaborative drug discovery scientists building an industry-leading portfolio of drugs for inflammatory and GI diseases with high unmet medical need. We are seeking a leader with significant experience in building and leading biology and cross-functional drug discovery teams to establish a new group focused on chronic autoimmune diseases. The Director Inflammatory Drug Discovery Will be responsible for developing industry-leading therapeutics for patients with inflammatory diseases by leading a research group focused on drug development from target identification through to candidate selection. Will recruit, retain, and develop a large team of world class, highly innovative in vitro and in vivo research biologists focused on understanding the molecular, cellular and organ-level drivers of inflammatory disease processes, and identifying and developing drug candidates. Will be scientific research thought leader within the Drug Discovery Unit (DDU), working within a highly matrixed environment to build an industry-leading preclinical and early clinical therapeutic pipeline for Inflammatory Diseases. Will set the discovery portfolio goals for high priority autoimmune diseases and ensure alignment with key stakeholders in inflammatory disease research, the clinical development team, and other Takeda stakeholders. Will be accountable for defining the preclinical elements of multiple drug discovery programs, in partnership with other research leaders across Takeda and the early clinical development team within the GI and Inflammation Therapeutic Area. Will interface with the business development group to identify strategically important innovative external opportunities Will help maintain the Takeda culture that promotes creativity, open communication, collaboration, collegiality, and a high sense of urgency. Maintain the highest quality of scientific foundations of the company’s drug discovery process. Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified. Forms a strong partnership with clinical and commercial team colleagues for disease area strategic alignment and is accountability for formulation and delivery of mid-long term innovative strategies to build a sustainable and innovative Inflammation disease area pipeline The Director Inflammation Drug Discovery will lead a team of researchers in early target discovery through candidate selection and partner with the therapeutic area Translational team in the development and delivery of robust early development plans supporting programs through early clinical proof-of-concept. The appointee will partner with the Center for External Innovation at Takeda for the identification and assessment of external platform and pipeline opportunities and be accountable for due diligence evaluation and recommendations on external opportunities in Inflammation diseases. Is seen as an international subject matter expert and identified as a global Takeda thought leader in the field of Inflammatory disease research and keeps up up-to-date with scientific, drug discovery and development and the external competitive environment. Represents Takeda and fosters a presence in the global inflammation and immunology scientific community through scientific meetings. Ensures and encourages diversity and supports individual colleagues and their reports in career development. Ensure that all Inflammation disease area Global Product Teams are resourced for optimal scientific support for research studies, mechanistic understanding, disease area evolution and competitive landscape understanding. Provides nuanced and well-informed advice to senior stakeholders about the GI and Inflammation therapeutic landscape, providing direction on where the science will lead. Leadership Creative, collaborative, proactive and confident individual with proven leadership qualities, as demonstrated by performance. Demonstrated ability to work across functions, regions and cultures and adheres to Takeda’s values Excellent communicator, able to persuasively convey both ideas and data, orally, in presentation and written format Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Interaction Effectively navigates the dynamics of external and internal environments and leads others by creating and inspiring and engaging workplace. Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions. Innovation Creative scientific thinker with excellent understanding of emerging technologies that enhance disease understanding and human-focused drug development programs Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the disease area-specific competitive landscape Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation. Ability to take risks implementing innovative solutions, accelerating time to market. Comfortable challenging the status quo and bringing forward innovative solutions. Role models respect and inclusion, creating a culture that fosters innovation. Education Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement ~ Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Advanced scientific degree (MSc, PhD, or PharmD) preferred. ~8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. ~ Knowledge of US and/or EU regulatory requirements and guidelines. ~ Knowledge of other relevant regional regulatory nuances and requirements. ~ Knowledge of scientific principles and regulatory/quality systems relevant to drug development. ~ CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. ~ Ability to develop target labeling profile (TLP) with minimal supervision and guidance. ~ Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as remote following Takeda's Hybrid and Remote Work policy. Massachusetts - Virtual The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. Promote sustainable practices and scalability in site-level regulatory operations. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies directions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions. Precedent Search and Labeling Trends Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience. Strategic Thinking Ability to develop execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately Read Less

Job Description

We know that a chef's job isn?t only about the food. It takes skills, dedication, patience, and the right opportunities. We?re looking for an Aramark Catering Sous Chef at Boston University who can help us deliver the best customer service and food experiences. Reporting to our Senior Executive Chef you?ll take a hands-on approach in focusing on team development, culinary expertise, safety protocol, and client relations. Our Catering Sous Chef will also play a key role in helping us meet budget requirements and execute company-delivered programs.

Just like you, we?re passionate about everything we do, and we?ll make sure you have the right growth opportunities to reach the peak of your career.

COMPENSATION: The salary range for this position is $75,000.00 to $87,000.00.? If both numbers are the same, that is the amount that Aramark expects to offer.? This is Aramark?s good faith and reasonable estimate of the compensation for this position as of the time of posting.

BENEFITS: Aramark offers comprehensive benefit programs and services for eligible employees including medical, dental, vision, and work/life resources. Additional benefits may include retirement savings plans like 401(k) and paid days off such as parental leave and disability coverage.? Benefits vary by location and are subject to any legal requirements or limitations, employee eligibility status, and where the employee lives and/or works.? For more information about Aramark benefits, Aramark Careers - Benefits & Compensation .

There is no predetermined application window for this position, the position will close once a qualified candidate is selected.? Qualified applicants with arrest or conviction records will be considered for employment in accordance with all applicable laws, including, but not limited to all applicable Fair Chance Ordinances and Acts. For jobs in San Francisco, this includes the San Francisco Fair Chance Ordinance.

Job Responsibilities

Further Description

Train and manage kitchen personnel and supervise/coordinate all related culinary and catering events activities

Estimate food consumption and requisition or purchase food?

Select and develop recipes as well as standardize production recipes to ensure consistent quality?

Establish presentation technique and quality standards, and plan and price menus?

Ensure proper equipment operation/maintenance and ensure proper safety and sanitation in kitchen?

Oversee special catering events and may also offer culinary instruction and/or demonstrates culinary techniques?

In order to meet our commitments, job duties may change or new ones may be assigned without formal notice.

At Aramark, developing new skills and doing what it takes to get the job done make a positive impact for our employees and for our customers. In order to meet our commitments, job duties may change or new ones may be assigned without formal notice.

Qualifications

Requires 2-3 years of experience in a related position

Requires 2-3 years of post-high school education or equivalent experience

Culinary degree preferred

Requires advanced knowledge of the principles and practices within the food profession

Requires experiential knowledge of management of people and/or problems

Requires oral, reading and written communication skills

About Aramark

Our Mission

Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet.

At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, sex, gender, pregnancy, disability, sexual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law.

About Aramark

The people of Aramark proudly serve millions of guests every day through food and facilities in 15 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at or connect with us on Facebook , Instagram and Twitter .

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Position/Department Summary
Performs a variety of routine and highly specialized diagnostic tests and specialized procedures. Assures quality of the results and communicates relevance of results to other health care professionals.

Key Responsibilities:Performing a variety of moderate and highly complex and diagnostic laboratory testing under general supervision in the laboratory.May perform specialized procedures in special laboratory sections unique to each laboratory's discipline.Evaluating whether the results are abnormal/critical and takes appropriate action internally/externally according to laboratory guidelines.Recording results of tests with all supporting documentation for clinical interpretation.Performing regularly scheduled quality control, preventative maintenance, and calibration of equipment according to laboratory guidelines. Performs all troubleshooting and repair.Participating in department continuing education including training program expanding scope of knowledge.Providing general assistance to less experienced laboratory personnel.Communicating principle/theory to physicians and other professional staff.Ensuring accurate test results by following good lab practices. Can identify problems as if unsure of resolution seeks appropriate assistance.Performing a variety of special projects and additional work as needed/assigned.Observing guides, verifying and checks documentation of less experienced lab personnel.Training and teaching laboratory personnel and others. Contributes to the continuing education programMay act as lead in absence of supervisor/manager. May prepare schedule or draft procedures.Performing a variety of moderate to highly complex and specialized diagnostic laboratory testing.Performing special projects as assigned.May perform testing unique to the specific discipline in the laboratory and at the bedside.
Minimum Qualifications
Education:Associate's Degree AND successful completion of an ASCP/NAACLS accredited Medical Technology/Medical Laboratory Science program requiredBachelor's Degree AND successful completion of an ASCP/NAACLS accredited Medical Technology/Medical Laboratory Science program preferred.
Experience:Minimum 3 years of Clinical Lab Science experience required5 years Clinical lab experience preferred
Certification:National certification preferredCertification required for related science degreed individualsShift/hours:Monday - Friday (4- 10 hour shifts), 7:00am - 5:30pm including occassional on call coverage for Needham when neededLocation:BostonSign on Bonus:$7,500 one time sign on bonusEmployee Referral bonus:$2,000.00

The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting.

Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project. Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines. Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams. Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum. Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions. Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions. Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners. Mentors junior staff to promote scientific excellence and individual achievement. Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies. Formulates and executes clinical pharmacology plans including integration of MIDD principles. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others). Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy. This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. No Phone Calls or Recruiters Please. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead - Solid Tumor in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees. Responsible for review of synopses, other relevant clinical study documents and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies. Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. Primary interface with Medical Affairs team for strategy and to support of product commercial efforts Contributing to the creation and maintenance of regional KOL network Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation ~ Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds.  ~ Trial Medical Monitoring ~ Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. ~ Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds.  Due Diligence, Business Development and Alliance Projects Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Assigns and manages clinical science staff who are involved in many of these activities. ~ Leadership, Task Force Participation, Upper Management Accountability Works with functional leadership to prioritize projects within the therapeutic area. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology ~ Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies ~ Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies. ~ Experience in conducting and/ or leading multiple clinical trials involving immune based therapies ~ Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment. ~ Demonstrated ability to foster a high-performance culture and build organizational capabilities. ~ Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives. ~ Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in EDC system and adherence to standards. Drive study database user acceptance testing activities in a role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system. Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration. Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business. Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing. Develop organizational knowledge of organizational clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables. Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes. Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc. Create and execute standardized test scripts for EDC components, inbound integrations, and data listings. Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected. Lead and coordinate End User Testing Activities, ensure that End User Testers have required training and system access. Communicate actively with management and clinical teams about testing progress and challenges. Support special projects and automated testing activities, including tool identification for manual UAT script automation. Provide technical support, liaising with CDE for troubleshooting and system issue resolution. Collaborate with cross-functional teams and vendors to ensure integration accuracy. Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDM ACCOUNTABILITIES Test Plan and Script Execution: Create and execute detailed test plans and User Acceptance Testing (UAT) scripts, ensuring alignment with business requirements and technical specifications. Validate study/library functionality within EDC systems and confirm adherence to established standards. Testing Strategy Development: Develop and enhance testing strategies for EDC system study/library builds and integrations. Stakeholder Collaboration: Network with key stakeholders to refine and improve study build automation and testing reduction strategies. Leadership in UAT Activities: Lead UAT for studies and libraries, including inbound integrations, using an Agile approach and in accordance with SOPs and processes. Coordinate and oversee End User Testing activities, ensuring testers are adequately trained and have necessary system access. UAT Documentation Development: Develop comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports. Standardized Test Script Creation: Develop and execute standardized test scripts for EDC components, inbound integrations, and data listings. Testing Results Analysis: Record and document test results, comparing them to expected outcomes. Identify software and specification failures for timely defect resolution. Communication and Reporting: Actively communicate with management and clinical teams about testing progress, challenges, and outcomes. Support for Special Projects: Assist in special projects and automated testing initiatives, including the identification of tools for manual UAT script automation. Technical Support and Troubleshooting: Provide technical support, collaborating with Clinical Data Engineering (CDE) for system troubleshooing and issue resolution. Cross-functional Collaboration: Work closely with cross-functional teams and vendors to ensure accuracy and efficiency in system integrations. Expertise in Clinical Data Systems: Demonstrate in-depth knowledge of electronic data capture, clinical data management systems, and related infrastructure. Utilize experience with various EDC systems (e.g., Veeva CDMS, Rave) and related clinical research technologies (e.g., eCOA, IRT, RTSM). S and Rave, Veeva CDB, elluminate Data Central, EHR, eCOA, IRT, RTSM, TSDV, CDR, MDR, SCE and adjacent systems. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS : BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with ~10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation. Experience with EDC and clinical data management systems. Familiarity with clinical research technologies (e.g., eCOA, IRT, RTSM). Experience in software testing and quality assurance. Proficiency in Agile methodologies and adherence to SOPs. Understanding of clinical data management processes and regulations. Strong problem-solving skills and attention to detail. Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. ADDITIONAL INFORMATION Requires approximately 1 - 2 domestic trips annually and up to 1 international trip. Ability to sit and stand for long periods of time. Carrying, handling, and reaching for objects. Manual dexterity to operate office equipment i.e., computers, phones, etc. This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team . At Takeda, we are transforming the pharmaceutical industry through our R D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s): Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned. ACCOUNTABILITIES: Accountable for planning and operational strategy and execution for assigned clinical trials. Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. Challenges study team to ensure operational feasibility, inclusive of patient and site burden Validates budget and ensures impacts are adequately addressed. Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy. Challenges study team to ensure timelines meet the needs of the clinical development plan. Ensure new team members and vendors are appropriately onboarded. During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place. Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly. Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs. Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted. Specific areas of sponsor oversight include, but are not limited to: Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring Review and endorsement of relevant study plans, as applicable Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections. Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior CSMs. May assist the program COPL in his/her role, as required EDUCATION AND EXPERIENCE: BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience. Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements. 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous. Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated excellence in project/program management and matrix leadership. Excellent communication skills. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $116,000.00 - $182,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal]] Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA . Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary Applies decisions taken by the company Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture Applies the given prioritization framework with limited support Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives and help shape how AI delivers real impact in drug discovery, we'd like to hear from you. Position Overview: We are seeking Scientists to develop and deploy foundational AI models that will transform drug discovery across Takeda. As part of the AI/ML Foundation team, you will build large-scale models including large language models (LLMs), diffusion models, and multimodal architectures that integrate diverse data types—omics, biomedical imaging, protein 3D structures, and molecular representations. This role requires deep expertise in modern deep learning architectures combined with foundational knowledge of biology, chemistry, and disease biology to ensure models are scientifically grounded and impactful. You will train models from scratch, fine-tune pre-trained models for Takeda-specific applications, and deploy foundation model capabilities that accelerate discovery across all therapeutic platforms. Accountabilities: Develop and train foundational AI models (LLMs, diffusion models, flow-matching architectures) for drug discovery applications, with capability to pre-train on large-scale scientific corpora and molecular datasets. Fine-tune and adapt pre-trained foundation models (protein language models, chemical LLMs, vision transformers) for Takeda-specific applications in target identification, disease modeling, and molecular design and discovery. Build multimodal foundation models integrating diverse data types including omics (genomics, transcriptomics, proteomics), biomedical imaging, protein 3D structures, and molecular representations. Apply and extend state-of-the-art approaches including graph neural networks, transformer-based protein language models, and multimodal learning frameworks. Apply domain expertise in biology, chemistry, and/or disease biology to guide model architecture decisions, training data curation, and evaluation strategies ensuring scientific validity. Implement state-of-the-art generative architectures (diffusion, score-based models, autoregressive transformers) for molecular generation, protein design, and multi-objective optimization. Collaborate with computational scientists across domains to deploy foundation models that address diverse discovery needs across small molecules, biologics, and emerging modalities. Stay current with advances in foundation models, generative AI, and multimodal learning; contribute to internal knowledge sharing and external publications. Education familiarity with Unix tools. Excellent collaboration and communication skills. ADDITIONAL INFORMATION The position will be based in Cambridge, MA Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $116,000.00 - $182,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Join us as a Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). Responsible for line management and provides expert counsel for issue resolution, including programs assigned to other staff, when required. Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations: Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines. The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi-functional leadership experience and skills to achieve program goals. Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met. Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees. Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy. Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy. Ensures communication of program status, cost and issues to inform timely decision-making by senior management. Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners. Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s). Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives. Bachelor’s Degree or international equivalent required, Life Sciences preferred. 12 or more years’ experience in pharmaceutical industry, including 9 or more years in clinical study management.  ~ Experience must include early phase experience or Phase 2 and 3 studies and global/international programs.  ~ Oncology experience is required. ~ Experience in more than one therapeutic area and in line management is advantageous. Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals. ~ Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. ~ Demonstrated excellence in project/program management and matrix leadership. ~ Fluent business English (oral and written). ~ takes measured risks; Massachusetts - Virtual The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Massachusetts - Virtual Full time LI-Remote Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Labeling Documents Authoring, Submission, and Labeling Negotiations In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement ~ Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Advanced scientific degree (MSc, PhD, or PharmD) preferred. ~10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience. Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately]] Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:  This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:  With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions. With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s) Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, supports CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Evaluates change proposals for global regulatory impact with some supervision. As a RA CMC member, ensures and/or enhances regulatory compliance . Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. ~6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA . Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. ~ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.  ~ Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. ~ Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. ~ Able to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. ~ Exercises good judgement in elevating and communicating actual or potential issues to line management.   At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Full time An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement ~ Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Advanced scientific degree (MSc, PhD, or PharmD) preferred. ~8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. ~ Knowledge of US and/or EU regulatory requirements and guidelines. ~ Knowledge of other relevant regional regulatory nuances and requirements. ~ Knowledge of scientific principles and regulatory/quality systems relevant to drug development. ~ CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. ~ Ability to develop target labeling profile (TLP) with minimal supervision and guidance. ~ Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as remote following Takeda's Hybrid and Remote Work policy. Massachusetts - Virtual The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. Read Less

Description Help save lives. Rapidly growing medical device manufacturer is looking to fill a "Sales Associate" position. Great opportunity to break into medical sales. They have a great compensation plan, extensive healthcare and retirement benefits packages. Company will also pay for your car, gas, expenses, cell phone, laptop, etc. You will be working with the most exciting, high tech operating room diagnostic, biopsy, equipment available. You will assist, in-service and case coverage of procedures performed at hospitals and ambulatory surgical centers. You will become and expert with a medical device and procedure. This product aids physicians to make early diagnosis and decide on treatment strategies to prevent disease progression. You will provide clinical, teaching, educational, technical and product knowledge support to existing and potential customers during surgical procedures. Build and maintain solid customer relationships and provide customer training at all levels. After 1.5 - 2 years you will be able to have your own territory as an account manager earning much higher income. QUALIFICATIONS * Bachelors Degree * At least 6 months outside sales experience Read Less

Description Citizens employs a group of experienced advisors that help individuals and families attain their financial goals. Our Wealth Advisors conduct thorough discoveries to understand a client's short- and long-term goals, then construct a tailored financial plan that meets the client's goals. The Citizens Wealth Advisor is a branch-based advisor who excels in a collaborative environment that emphasizes the paramount importance of client interests, as well as the personal and professional growth of team members. Wealth Advisors work directly with a variety of business partners and centers of influence to uncover and identify prospective opportunities. Primary responsibilities include Develop a high-quality wealth management practice that provides a personalized wealth management strategy. Enhance and preserve relationships with key partners to boost client introductions and engagement. Proactive client and prospect outreach promoting Citizens Wealth Management capabilities. Grow existing relationships through partnership referrals. Tailor wealth management planning to meet client needs. Utilize the knowledge of internal stakeholders and specialists in delivering a variety of services, including financial planning, investment management, insurance, and estate planning. Qualifications, Education, Certifications and/or Other Professional Credentials Series 7, 63, 65 (or 66) active and valid. A valid, active Insurance Life/Health/Variable licenses is required or must be obtained within 60 days of starting the role as a condition of employment. A minimum of 2 years in a Financial Advisor role or equivalent experience in financial services. Demonstrated track record in new business development and client book management. Proven experience in a team-oriented consumer bank setting. Familiarity with servicing high-net-worth individuals. Comfortable operating in a dynamic, entrepreneurial environment. Bachelor's degree is preferred. Pay Transparency Commissioned based. Individuals in this role have historically earned between $105,000 and $250,000 per year based on performance and productivity against commission plan parameters. For an overview of our benefits, visit https://jobs.citizensbank.com/benefits. We offer competitive pay, comprehensive medical, dental and vision coverage, retirement benefits, maternity/paternity leave, flexible work arrangements, education reimbursement, wellness programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid time-away policy of every local and state jurisdiction in the United States. For an overview of our benefits, visit https://jobs.citizensbank.com/benefits. Hours Work Schedule Hours per Week: 40 Work Schedule: M-F (Branch Hours) Some job boards have started using jobseeker-reported data to estimate salary ranges for roles. This sales role is commission-based. If you apply and qualify for this role, a recruiter will discuss accurate pay guidance. Equal Employment Opportunity Citizens, its parent, subsidiaries, and related companies (Citizens) provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, ancestry, color, citizenship, physical or mental disability, perceived disability or history or record of a disability, ethnicity, gender, gender identity or expression, genetic information, genetic characteristic, marital or domestic partner status, victim of domestic violence, family status/parenthood, medical condition, military or veteran status, national origin, pregnancy/childbirth/lactation, colleague's or a dependent's reproductive health decision making, race, religion, sex, sexual orientation, or any other category protected by federal, state and/or local laws. At Citizens, we are committed to fostering an inclusive culture that enables all colleagues to bring their best selves to work every day and everyone is expected to be treated with respect and professionalism. Employment decisions are based solely on merit, qualifications, performance and capability. Why Work for Us At Citizens, you'll find a customer-centric culture built around helping our customers and giving back to our local communities. When you join our team, you are part of a supportive and collaborative workforce, with access to training and tools to accelerate your potential and maximize your career growth Background Check Any offer of employment is conditioned upon the candidate successfully passing a background check, which may include initial credit, motor vehicle record, public record, prior employment verification, and criminal background checks. Results of the background check are individually reviewed based upon legal requirements imposed by our regulators and with consideration of the nature and gravity of the background history and the job offered. Any offer of employment will include further information. Read Less

Clinical Director We Are Offering A $2,000 Sign-on Bonus! Who We Are Looking For: Are you the Clinical Director we have been looking for? In this position you will be able to convey your passion for helping others by supporting our clients to achieve their goals! JRI's Boston GLASS program is dedicated to providing a continuum of services to LGBTQIA+ youth of color and their allies in the Greater Boston and Greater Framingham areas. As a leader in LGBTQIA+ youth services, we also provide education and consultation to other providers and community organizations. Our Behavioral Health Services Manager guides staff, community partners, and individuals to support LGBTQIA+ rights, needs, growth and well-being in a variety of forms everyday. Compensation: The pay range for this position is $75,000 to $102,000 per year. The listed range reflects what we reasonably and in good faith expect to pay for this role at the time of posting the position. The actual compensation an employee is offered may vary based on several factors such as experience, education, licensure, certifications and qualifications. This range may be modified in the future. Sign-on Bonus: We are offering a $2,000 sign-on bonus ($1,000 paid after 3 months of employment and another $1,000 paid after 6 months of employment). JRI Provides The Training So That: YOU will be able to continue to develop and utilize your clinical skills, managerial skills and overall leadership skills to guide effective trauma-based treatment for all people that GLASS serves. YOU will be able to develop and utilize your leadership skills by providing complete oversight of behavioral health services, including managing outpatient and CBHI clinical staff. YOU will be able to ensure that all staff are working toward a shared mission and vision of the program and provide clinical supervision for licensed clinicians and clinical interns. YOU will identify, assist families in accessing, and monitor available services and holistic supports for youth and families. YOU will provide trauma informed services that center the needs of each unique individual we serve. YOU will provide guidance to assist staff in being a support to parents and caregivers in learning effective advocacy skills. Why JRI? Be who you are! JRI is committed to creating a workplace built on respect, collaboration, and opportunity, where every employee is valued and supported in making a meaningful impact. We offer a $2,000 bilingual bonus to new hires who speak a second language fluently, other than English, and will use it to serve our clients! Reimbursement is available for employees to cover the registration costs and annual fees for any professional license required for work such as LMHC, LCSW, LICSW, RN and more! Access to our excellent Blue Cross medical and Delta Dental benefits. Retirement benefits including 401K matched up to $800 a year and pension after 5 years of employment. Professional development opportunities such as tuition reimbursement up to almost $4000 per year and discounted tuition rates to select partnership colleges and universities! Wellness benefits including access to employee engagement groups, self-care resources, and an Employee Assistance Program. Generous paid time off up to 19 days for full time employees in your first year and much more! Requirements: Candidates must have a minimum of Master's degree in Social Work, Psychology, Counseling or related field from an accredited college or university. Candidates need to be independently licensed (LICSW/LMHC/LMFT). Must have daily access to reliable, insured vehicle and active Driver's License. Must be willing to maintain a flexible work schedule. 2-3 years of providing behavioral health services to LGBTQIA+ youth of color and their allies; experience working with specialized population of adolescents preferred. Knowledgeable in youth development; able to obtain and interpret information in terms of the needs of youth; understanding of the range of interventions and treatment required by this population. Background and driving record checks will be performed. At JRI, we are committed to fostering a workplace where every team member feels valued and respected. We believe that a culture built on mutual respect, collaboration, and opportunity allows our staff to thrive and do their best work. By supporting one another and recognizing each person's contributions, we create an environment where people can grow, develop their skills, and make a meaningful impact in the communities we serve. JRI is an equal opportunity employer. #INDDIR Read Less