- Cardinal Health (Boston, MA)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Merck (Boston, MA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical trials start-up, active and close out phases. + Proficient knowledge of regulatory affairs , research ethics and the responsible conduct of research + ... The Assistant Regulatory Operations Manager (AROM) is a...research portfolio. This position involves close collaboration with the Clinical Research Manager within the Leukemia disease… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- ThermoFisher Scientific (Cambridge, MA)
- …* Collaborate with cross-functional individuals from Registry Operations, Medical Affairs , Quality/ Regulatory , Project Management, Biostatistics, Epidemiology in ... development and delivery of life-changing therapies. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data… more
- Edwards Lifesciences (Boston, MA)
- …assigned Regional Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. ... around the world. As a part of the Field Clinical Specialist team, you will be a critical part...and support staff trainings. + Collaborating with the Territory Manager on growing the THV therapy through therapy awareness… more
- Sumitomo Pharma (Boston, MA)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in clinical research field is preferred. + Must have knowledge of regulatory affairs , research ethics and the responsible conduct of research. **KNOWLEDGE, ... participate in periodic meetings with internal and external collaborators. + Assist Clinical Research Managers or Senior Translational Project Manager (s) with… more
- State of Massachusetts (Boston, MA)
- …and the Program of All Inclusive Care for the Elderly (PACE).*__* *The Program Manager , Adult Foster Care and Group Adult Foster Care Programs*manages a network of ... all inclusive)_**:* * Collaborate with the Strategic Initiatives team, the Senior Manager and theProgram Integrity team in managing day-to-day interaction with the… more
- Dana-Farber Cancer Institute (Brighton, MA)
- … clinical research field is preferred. + Must have strong knowledge of regulatory affairs , research ethics and the responsible conduct of research. **REQUIRED ... Manager will work independently under general supervision of a more senior manager within their disease group or Clinical Trials Office. This position may… more
- Edwards Lifesciences (Boston, MA)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Experience in an academic institution is preferred + Must have expert knowledge of regulatory affairs , research ethics and the responsible conduct of research. + ... Will have supervisory responsibilities to include overseeing Research Assistants, Clinical Research Coordinators, and regulatory coordinators. + Master's… more
- Takeda Pharmaceuticals (Boston, MA)
- … Oncology. You will work cross-functionally with but not limited to Clinical Operations, Legal, Regulatory , Procurement, Patient Value Access and Safety. ... and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Evidence Generation, Global Medical… more
- Fujifilm (Boston, MA)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more
- Sanofi Group (Cambridge, MA)
- …Collaboration** + Foster strong partnerships with medical affairs , public affairs /advocacy, market access, market research, legal, regulatory , and other ... **Job Title:** Global Senior Marketing Manager **Location** : Cambridge, MA **About the Job**...the brand strategies + Work closely with Global medical, regulatory , and legal to ensure all marketing materials comply… more
- Tufts Medicine (Boston, MA)
- …goals. In addition, this role focuses on performing the following Clinical Administration duties: Long-term strategic planning, determines strategic issues and ... as described in the Medical Staff Bylaws and various accrediting and regulatory agencies. 15. Provides close support to the medical department Chair/Chief(s) to… more
- AbbVie (Boston, MA)
- …(eg, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical ... is seeking an experienced statistician to join our growing Safety Statistics team. The Senior Manager in the Safety Statistics Group will be a member of one or more… more
- Integra LifeSciences (Boston, MA)
- …may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed ... to help improve outcomes. **SUMMARY** This position reports to the Plant Manager and is responsible for manufacturing engineering at the Integra Tissue Technologies… more
- Sanofi Group (Cambridge, MA)
- …plans and future research + Exhibit a high degree of scientific and clinical knowledge in the therapeutic field to help identify and critically assess research ... and appropriate communication and collaboration among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining… more
- State of Massachusetts (Boston, MA)
- …of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making sure the professionals ... and its licensees. The Executive Director ("ED") will lead the administration and regulatory functions of the Unit, including collaboration with the BBRS and its… more