- Merck (North Wales, PA)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy ... global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. + Develops worldwide… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and...and/or disease education communications + Serve as the company's regulatory liaison to the FDA's Advertising and… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...the GRL, may lead regional Health Authority meetings and liaison with local Health Authority and company governance boards… more
- Sumitomo Pharma (Trenton, NJ)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...Health Authorities + Leads the regional health authority meetings, liaison with local Health Authority, + Document owner of… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global … more
- Merck (North Wales, PA)
- **Job Description** **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development and ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. **Key Functions**… more
- Ascendis Pharma (Princeton, NJ)
- …projects to both internal and external audiences within legal, compliance and regulatory guidelines. + Represent Ascendis Medical Affairs internally and ... Medical Director Do you want to be part of building...well functional projects as part of the US Medical Affairs Team. They will be accountable and help the Head… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …and study timelines. + Serves internally as clinical development expert for global regulatory interactions; collaborate with Regulatory Affairs in planning ... Senior Director , Clinical Development - Neurology **Date:** Dec 10,...will provide clinical development support and guidance into global regulatory interactions, will assist the Medical Affairs … more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... to make a difference? The Position The International Medical Director serves as a subject matter expert for our...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …targets and study timelines Serve as internal as clinical expert for global regulatory interactions; collaborate with Regulatory Affairs in planning ... Medical Director , Clinical Development - Hematology **Date:** Dec 20,...S/he will provide clinical support and input into global regulatory interactions and serve as the clinical lead for… more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... make a difference? The Position The Senior International Medical Director serves as a subject matter expert for our...Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** US Medical Director , Mainline Vaccines **Location** : Bridgewater, NJ / Morristown, NJ **About the Job** The North American Medical Team at Sanofi is ... millions of patients around the world. **Main Responsibilities:** The US Medical Director , Mainline Vaccines, will contribute to development and execution of the… more
- J&J Family of Companies (Horsham, PA)
- …Cross-Functional Collaboration- Partner with various cross-functional teams, including medical affairs , compliance, regulatory , clinical operations, scientific ... Johnson & Johnson, is recruiting for an Associate Director , Pathway Strategy (Hematology) to be located in...Contribute to pathway development by aligning with clinical standards, regulatory requirements, and market trends. + Data Analysis and… more
- Penn Medicine (Bala Cynwyd, PA)
- …DOH regulations, and TJC accreditation standards suggested.Working under the leadership of the Director of Regulatory and Patient Affairs and close ... future each day. Are you living your life's work? Summary: + The Regulatory and Accreditation Specialist establishes and implements regulatory standards and… more
- University of Pennsylvania (Philadelphia, PA)
- …Job Title Compliance Manager, Office of Animal Welfare Job Profile Title Associate Director D, Animal Health Job Description Summary The Office of Animal Welfare ... testing, and teaching. The Compliance Manager, reporting to the Director of Animal Welfare Programs and Operations, is tasked...broader research community at Penn. Serving as a senior-level liaison and subject matter expert, they will engage with… more
- Penn Medicine (Philadelphia, PA)
- …are maintained for each determination performed; manage personnel, and all fiscal affairs . Responsibilities: Technical Services: + With Medical Director , sets ... + Works with the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site visits,… more
- Penn Medicine (Philadelphia, PA)
- …affairs . **Responsibilities** : + Technical Services: With Medical Director , sets strategic direction of section; Approves/develops standard operation procedures; ... Compliance: Works with the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site… more
- University of Pennsylvania (Philadelphia, PA)
- …guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and ... implement a plan of action; will work with the regulatory manager to ensure that submissions to the IRB...provide monthly updates to the research team and the director . This role requires a combination of both comprehensive… more
- University of Pennsylvania (Philadelphia, PA)
- …of budgets and coordination of those sites. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and ... implement a plan of action; will work with the regulatory manager to ensure that submissions to the IRB...provide monthly updates to the research team and the director . This position is necessary to support our research… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …and trial design specific to drug delivery and feasibility, acting as a liaison between potential investigators and Medical Affairs , and supporting data and ... pharmaceuticals, marketing, sales, research and development, strategy and portfolio management, regulatory , technical services, and medical affairs team members.… more