• This Job at a Glance Job Reference Id: ORD-203619-MD-MA Title: MD Date... Read More
    This Job at a Glance Job Reference Id: ORD-203619-MD-MA Title: MD Dates Needed: As soon as credentialed - Full time Shift Type: Day Shift Assignment Type: Inpatient Call Required: Yes Board Certification Required: Yes Job Duration: Locums About the Facility A Rehabilitation Hospital is seeking a PM Read Less
  • Senior Director, Clinical Data Standards (BOSTON)  

    - Suffolk County
    By clicking the “Apply” button, I understand that my employment applic... Read More
    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
  • This Job at a Glance Job Reference Id: ORD-192898-CRNA-MA Title: CRNA... Read More
    This Job at a Glance Job Reference Id: ORD-192898-CRNA-MA Title: CRNA Dates Needed: October - ongoing Shift Type: Day Shift Assignment Type: OR Call Required: No Board Certification Required: Yes Job Duration: Locums About the Facility A hospital is seeking a CRNA for locum tenens coverage. About the Facility Location The facility is located west of Boston, Massachusetts. About the Clinician's Workday This opportunity includes a variety of cases such as Bread and Butter, OB, Thoracic, OBGYN, and Complex General. Shifts are scheduled on weekdays from 7 AM (8 AM on Wednesdays) and typically run 10-12 hours. The facility uses EPIC for EMR. Credentialing takes approximately 6-8 weeks. The position includes a mix of supervision and solo work, with potential for overnight and weekend shifts. Additional Job Details Case Load/PPD: Varies Location Type: On-Site Prescriptive Authority Required: No Government: No Percentage Hands On: 0% Supervision/Medical Direction: Supervision 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
  • Medical Group is seeking a full-time BC/BE Ophthalmologist to join a w... Read More
    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
  • A

    Catering Sous Chef - Boston University  

    - Boston
    Job Description We know that a chef's job isn?t only about the food. I... Read More
    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 applic... Read More
    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 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 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). Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values. Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives. May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence. ​ EDUCATION AND EXPERIENCE: Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable. 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. Supervisory experience. Demonstrated excellence in project/program management and matrix leadership. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). Able to influence without authority. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge 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: $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 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
  • Director, Regulatory Site CMC (BOSTON)  

    - Suffolk County
    By clicking the “Apply” button, I understand that my employment applic... Read More
    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 Read Less
  • By clicking the “Apply” button, I understand that my employment applic... Read More
    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:  Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle.   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.  Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.  Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. As a GRA 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.   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. Proactively identifies regulatory CMC risks, ensuring timely communication with line management.  Leads assigned global regulatory submissions (e.g., Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.  Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., 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 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. ~ Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.  ~ Strong 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  ~ 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 lon]] Read Less
  • By clicking the “Apply” button, I understand that my employment applic... Read More
    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
  • Director, Global Regulatory Lead - Oncology (BOSTON)  

    - Suffolk County
    By clicking the “Apply” button, I understand that my employment applic... Read More
    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 experience as a significant contributor to regulatory and/or development strategies Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate strong skills with increasing independence in the area of regulatory strategy. Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership. Strong and independent skills in 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: $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
  • Senior Leader of Regulatory Operations CMC (BOSTON)  

    - Suffolk County
    By clicking the “Apply” button, I understand that my employment applic... Read More
    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 (M.S., Ph.D., etc.) required. 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Strong 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 minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Applies direction 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. 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: $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 lon Read Less
  • By clicking the “Apply” button, I understand that my employment applic... Read More
    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
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    Company Description Job Description Dominos Pizza on Boston RD in Springfield MA is now hiring Part Time and Full Time Pizza Makers. Are you in school or have another job? No problem we offer great schedule flexibilities. Must be able to work Nights and Weekends. Must be 18 years or Older to Apply Did you know that 90% of our Franchisees started as Pizza Makers? We offer Great Career opportunities!! Pay Transparency (In accordance with the Massachusetts Salary Range Transparency Law, effective October 29, 2025) Pay Ranges (Massachusetts) Delivery Drivers $18.00 - $25.00 per hour (Includes Tips + Gas Reimbursement) Insiders $15.50 - $17.00 per hour Assistant Managers $17.00 - $19.00 per hour (Plus, the opportunity to receive Operational Excellence Incentives, PTO and Career Advance Opportunities) General Managers $20.00 - $30.00 per hour (Plus Operational Excellence Incentives Read Less
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    Medical Lab Scientist II - Boston  

    - Boston
    Position/Department SummaryPerforms a variety of routine and highly sp... Read More
    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.

    Read Less
  • By clicking the “Apply” button, I understand that my employment applic... Read More
    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 applic... Read More
    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
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