- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... to the best of my knowledge. **Job Description** **Senior Manager , US Medical Ad/Promo Regulatory Review** **Takeda... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… 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
- State of Massachusetts (Boston, MA)
- …maximize their skills and talents to serve our citizens. *_About the Role:_* The Manager of Regulatory and Public Data Analysis will be responsible for managing ... concerning the Division's duties as the regulator of Massachusetts insurance markets. The Manager of Regulatory and Public Data Analysis will manage the… more
- Actalent (Cambridge, MA)
- …PharmD, or PhD preferred. + Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs ... Description + Actively represent Regulatory on interdisciplinary teams (eg CMC Teams, Program...product development strategy. + Lead quality portions of global clinical trial applications including the preparation of initial INDs/CTAs/GMOs… 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
- ICON Clinical Research (Boston, MA)
- …understanding of the medical device regulatory process in collaboration with Regulatory Affairs and providing essential support during internal and external ... through design phases. + Coordinate with cross-functional teams, including R&D, Regulatory Affairs , Quality Assurance, and Manufacturing, to ensure cohesive… 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 (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
- 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
- AbbVie (Waltham, MA)
- …(Biomarker research, Regulatory , Pathology, Clinical Science, Biosample Management, Clinical Operations and Medical Affairs ) + Manage activities and tech ... a highly motivated individual to join our Precision Medicine team as a Manager , Companion Diagnostics Operations. The CDx Operations Manager will work closely… 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
- 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
- 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
- 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