- 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
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …of the VAMC. The C&P Analyst is aligned to and supervised by the C&P Manager . This position is full-time at 40 hours per week. Responsibilities The position is ... FPPE and the OPPE for the C&P Program. Analyzing clinical evaluation plans to assure that they meet standards...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus… 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
- 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
- Hologic (Marlborough, MA)
- …in partnership with other functional leads + Works collaboratively with clinical affairs , outcomes research, and scientific communications to identify ... Sr Manager , Medical Relations Marlborough, MA, United States As...Development: Experience leading and developing high performing teams + Clinical Acumen: Ability to absorb clinical data… 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
- 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
- Hologic (Marlborough, MA)
- …Strategy, Government Affairs , Health Economics & Outcomes Research, Medical Relations, Regulatory Affairs and Sales. Successful candidates will come from a ... Sr Manager , Market Access Marlborough, MA, United States **Job...business development initiatives to optimize commercialization + Collaborate with clinical functions on evidence generation strategy and needs to… more