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 Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD) 20+ years of industry experience with significant experience in Global Regulatory Affairs CMC (or closely related CMC regulatory experience), including leadership for small molecule and/or biologic products in early development Significant experience leading, reviewing, authoring, or managing CMC content for global regulatory submissions and responses in early development (e.g., pre-IND/IND, CTA/IMPD, amendments, briefing packages, and major deficiency responses) and negotiating requirements with health authorities Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH guidance and regional expectations (FDA, EMA, MHRA, PMDA); experience across additional regions a plus. Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to CMC regulatory requirements and strategy, including impurity risk, analytical control strategy, specifications, stability strategy, and comparability (as applicable). Demonstrated ability to drive fit-for-phase global CMC regulatory strategy, leveraging prior knowledge, platform capabilities, and risk-based approaches; experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrated ability to think strategically and operate with increasing independence, understanding implications across the organization and globally; proactively identifies CMC regulatory issues and offers innovative, risk-based solutions and 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: $238,000.00 - $374,000.00 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 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 Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations Standards. 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: In collaboration with the Clinical Data Strategy Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives strategy of Takeda’s global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability. Responsible for establishing and managing a Standards vendor to support Standards Management vision. Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough assessment of library enhancements and deviations. Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation. Participates with and influences at industry standards forums in support of Takeda’s therapeutic areas. Serves as a resource to support questions raised by regulatory agencies. A CCOUNTABILITIES: Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum. Works with Clinical Data Strategy Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy. Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization. Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives. Supervises staff and vendors developing standards library to ensure alignment to standards strategy. Develops training strategy and ensures consistent training program for standards. Provides senior oversight to vendor/CROs for utilization of Takeda standards. Conducts ongoing review and development of metrics to assess standards utilization and development trends. Oversees Standards Governance, managing deviations from standards content and processes. Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc. Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization. Complies with all applicable regulatory expectations. ​ EDUCATION AND EXPERIENCE: BS/BA or MS in a life science or analytical area. 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field. 8+ years of experience supporting clinical trials across all phases of development. 5+ years of progressive management experience. Proven track record for development and management of a standards library. In-depth knowledge of data management systems and processes, analysis and reporting principles. Good knowledge of statistical programming languages (e.g. SAS). Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS. Expertise in the requirements and technology required to support electronic data capture and electronic submissions. Proven track record in identifying and implementing organization-wide initiatives, standards, and processes. Proven track record in managing global, cross-functional standards and processes. Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.) Able to influence without authority. Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo. Pragmatic and willing to drive and support change. Is comfortable with ambiguity . Support a culture of continual improvement and innovation; promote knowledge sharing. 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: $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, 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 Massachusetts - Virtual 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. #LI-Remote Read Less

Medical Group is seeking a full-time BC/BE Ophthalmologist to join a well-established and growing practice. Excellent opportunity for a new grad or experienced physician! Excellent support staff EPIC EMR Well established patient panel Office based, independent private practice-like settings Extensive network of specialists Our comprehensive services include cutting-edge procedure and personalized care for all ages On-site optical shop Competitive compensation including guarantee period and RVU bonuses Sign on bonus and relocation package Generous PTO and CME time Medical, Dental, Optical and Malpractice with tail Retirement plan with high employer contribution Read Less

This Job at a Glance Job Reference Id: ORD-210153-DNP-MA Title: DNP Dates Needed: June 1st - 6 months Shift Type: Day Shift Assignment Type: Outpatient; Clinic Call Required: No Board Certification Required: Yes Job Duration: Locums About the Facility This Federally Qualified Health Center provides comprehensive primary care services to the community with a focus on accessible healthcare delivery. The facility operates with full support staff including dedicated medical assistants, registered nurses, and physicians to ensure efficient patient care coordination. Credentialing requires approximately two months for completion. About the Facility Location Just outside of Boston, youll find a mix of charming historic towns, scenic coastal escapes, and unique attractions that make quick getaways from the city incredibly easy! About the Clinician's Workday The nurse practitioner will provide comprehensive family medicine services in a Federally Qualified Health Center setting, managing adult patients 18 and older with diverse primary care needs. Daily responsibilities include conducting patient evaluations, managing chronic conditions, and providing preventive healthcare services while maintaining accurate medical records. The clinician will work flexible schedules with options for administrative time organization, participating in minimal call coverage approximately once every four weeks with support from nursing staff for initial triage. Collaboration with dedicated medical assistants, registered nurses, and physicians ensures optimal patient outcomes within the FQHC healthcare delivery framework. Additional Job Details Case Load/PPD: ~20 Support Staff: Dedicated medical assistant and registered nurse with additional physicians on staff Patient Population: Adults Location Type: On-Site Prescriptive Authority Required: Yes Government: No Why choose LocumTenens.com? Our services are 100% free for clinicians and are designed for a seamless experience with every assignment: Precision job matching with proprietary algorithm Rapid credentialing with Axuall Digital Wallet Concierge support with a dedicated clinician deployment specialist Digital hub for assignment details Read Less

About Langham Hospitality Group A wholly-owned subsidiary of Great Eagle Holdings, Langham Hospitality Group (LHG) comprises a family of distinctive brands, including The Langham Hotels and Resorts, Cordis Hotels and Resorts, Eaton Workshop and Ying'nFlo. With over 40 hotels and residences in operation or development, LHG has a global footprint that extends across Asia, Europe, North America, Australasia and the Middle East. LHG's approach to hospitality centres on open and genuine interactions with guests, colleagues and the world around us. With dedicated colleagues across four continents, we foster an engaging and respectful workplace to nurture careers, delight guests, and embrace the company's vision to building great memories together. The Langham, Boston is one of the city's most historic hotels and one of the most iconic luxury hotels in the US. You will be assisting to lead a passionate talented Food Beverage team to drive excellence in guest experience and the overall success of Outlet Kitchens including Grana, The Fed and Private Kitchen, by delivering high standards in guest experience colleague engagement in alignment with the culture and values of Langham Hospitality Group. Key Responsibilities: To oversee production and execution of food preparation for outlets. Organize, oversee, and participate in the plating of food for service, according to established plating and presentation criteria. Ensure the food is of the highest quality and ready to be served to the guest at the appropriate time. Assist in controlling costs by effective purchasing of food and maintaining food cost goals as well as monitoring labor levels. Manage day-to-day staffing such as coaching and counseling, disciplinary actions, and overall kitchen morale. Maintain a professional presence while staying calm and confident. Meet the guest needs by developing and maintaining effective relationships in both internal and external customers. Have the knowledge of local health rules, regulations, and food handling. Qualifications: Experience with menu development, costing, and BEO distribution. Advanced knowledge of culinary technique and application. Ability to adapt to changing demands as related to a banquet kitchen, minimum 2 years of Banquet Kitchen experience. Degree in Culinary Arts preferred, 2 to 4 years' experience in a 4-5 star hotel or independent restaurant in a kitchen management role. Abides by local and national food safety requirements and ensures that others do so by monitoring FIFO inventory and visually inspecting food preparation, delivery activities, and overall cleanliness of the operation. ServSafe certification. Legally authorized to work in the United States. Salary Range: $85,000 - $90,000 annually For more information about the property, please visit: https://www.langhamhotels.com/en/the-langham/boston/ 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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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 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. To do this, we empower our people to realize their potential through life-changing work. 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. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda is a global, values-based, R working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD Technical Skills: 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. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-JV2 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: $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 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 creat]] 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 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 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. Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. 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. Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed. Providing strategic input into global development strategies and plans for all compounds in OTAU. Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities) 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 Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation Synopsis / Protocol Development, Study Execution, 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 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; while maintaining awareness of recent in-class approvals. 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. Represents global labeling 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. 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. 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. Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). 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. Ability to create, revise and/or update product labeling (i.e. 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. Understanding of the broad concepts within global labeling and implications across the organization and globally. Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. 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 remote following 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 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 medic 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 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:  With minimal supervision, develops and 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 serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.   Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.  With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.  With supervision, may represent Takeda RA CMC in Health Authority meetings and support 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. As a GRA CMC member, ensures regulatory compliance with HA regulations. 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.    Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.  When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target.  Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. BS/BA Degree in a Scientific Discipline, Advanced Degree (M.10+ years of overall biopharmaceutical/device industry experience with 5+ 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 minimal supervision. 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. 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 understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. 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 in accordance with 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: Boston, MA 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 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 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. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experience Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence 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. 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. This position is currently classified as “hybrid” in accordance with 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: Boston, MA 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 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 Advanced degree in a scientific, or engineering discipline (e.g., MS, PhD, PharmD) 20+ years of industry experience with 10+ years in Regulatory Affairs and demonstrated leadership in medical devices and/or drug-device combination products. Significant experience leading, reviewing, authoring, or managing regulatory submissions for devices and/or combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation), including major deficiency responses and negotiation of requirements. Strong working knowledge of device and combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance obligations; experience with other regions a plus. Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy. Provides expert guidance on global device/combination regulatory strategy, including technical documentation/Design History File expectations, design controls, human factors/usability, biocompatibility, software and cybersecurity considerations (as applicable), and post-market lifecycle planning. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence 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 innovative 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: $238,000.00 - $374,000.00 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 ]] 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. Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. The Associate Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.  Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. 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. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Bachelor’s Degree, scientific discipline strongly preferred ~ Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred  ~6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experience ~ Preferred experience in reviewing, authoring, or managing components of regulatory submissions.  ~ Solid working knowledge of drug development process and regulatory requirements. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. ~ Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. ~ Demonstrates strong skills with increasing independence 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. ~ 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. This position is currently classified as “hybrid” in accordance with 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

Territory Manager BD is seeking a highly motivated and skilled Territory Manager to join our Biotechnology and Medical Devices team. In this role, you will be responsible for driving sales growth, developing new business opportunities, and providing exceptional customer support within your designated territory. As a Territory Manager, you will position yourself as a product specialist, educating healthcare professionals on the effective utilization of our innovative solutions. Responsibilities Achieve established sales goals and drive revenue growth within your assigned territory. Develop and maintain strong relationships with existing customers while actively pursuing new business opportunities. Provide on-site technical support and training to healthcare professionals, ensuring accurate and effective use of BD's products. Stay up-to-date with the latest product information and industry trends to deliver valuable insights to customers. Collaborate with cross-functional teams to identify and address customer needs, ensuring prompt and satisfactory resolution of any concerns. Represent BD at industry events, tradeshows, and customer meetings, delivering compelling presentations and fostering positive brand recognition. Requirements Bachelor's degree in a relevant field required. Minimum of 3 years of sales experience, in the medical or healthcare industry preferred. Excellent interpersonal, communication, and presentation skills. Strong understanding of sales strategies, contract administration, and group purchasing principles. Ability to travel extensively, including overnight stays, within your assigned territory. Must possess and maintain a valid state-issued driver's license and meet BD's auto safety standards. Willingness to undergo regular drug screenings as per customer/medical facility requirements. At BD, we are strongly committed to investing in our associatestheir well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under "Our Commitment to You". Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles. $125,992 - $207,888 - Base + Incentive At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work Location: USA RI - Warwick Additional Locations Work Shift Read Less

Sales Advisor As a Sales Advisor, you'll be responsible for providing excellent customer service, welcoming Read Less

Long established, privately owned service based company with outstanding corporate culture is looking for an outside sale rep for an expansion territory. Will be based out of your own home office. All expenses covered, car allowance, parking, tolls, great benefits including family medical, dental, vision, 401k. Substantial base salary and uncapped commissions compensation plan. Call points are post-acute care facilities such as surgery centers, physicians' offices, dental offices, Long Term Care facilities, etc. This is an outstanding entry level medical sales opportunity. REQUIREMENTS * Minimum 2yrs OUTSIDE business to business sales experience with documented success. * Bachelor's degree Read Less