- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between NNI and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...(territory and account) plans in coordination with his/er Field Director . Relationships Position reports to Field Director /Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... this position serves as the RA CMC representative supporting company initiatives ( liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections).… more
- Tris Pharma (Monmouth Junction, NJ)
- …Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid position. ... with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership and direction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison field team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...plans to support marketing product claims. + Acts as liaison between Regulatory Affairs &… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and… more
- Danaher Corporation (Raleigh, NC)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...CMC submission in INDs, BLAs, NDAs, etc. + Primary liaison for communications with FDA and other regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... advertising and promotion of pharmaceutical products. + Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… 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** Reports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Abbott (Princeton, NJ)
- …operational performance. Our location in Princeton, NJ currently has an opportunity for a Director of Medical Affairs , Americas. The Director of Medical ... Liaison (MSL) team, as well as representing Medical Affairs internally & externally. The MSL team members each...You'll Work On** + Reporting directly to the Sr. Director , Global Medical & Scientific Affairs (GMSA),… more
- AbbVie (Mettawa, IL)
- …discovery, statistics, regulatory , etc) as they relate to on-going medical affairs projects. May assist as consultant/ liaison with other corporations when ... regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and ...affairs projects. + May assist as consultant and liaison with other corporations when working under licensing agreements… more
- Gilead Sciences, Inc. (Washington, DC)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Senior Director , Federal Government Affairs ** **Job Overview:** Reporting to the ... Vice President of Federal Government Affairs , the Senior Director , Federal Government ...and engagement, working cross-functionally with legal, commercial, and public affairs colleagues to advance Gilead's legislative and regulatory… more
- Inovio Pharmaceuticals (Plymouth Meeting, PA)
- …Science Liaison (MSL) and Clinical Device Liaison (CDL) teams. The National Director , Field Medical Affairs (FMA) will report to the VP of Medical ... more information, visit www.inovio.com . Job summary The National Director , Field Medical Affairs (FMA) will be...Ensures field compliance of all relevant corporate policies and regulatory guidelines. + Ensure all Field Medical materials and… more
- Integra LifeSciences (Princeton, NJ)
- …in the Marketing, Business Development, R&D/Process Technologies Clinical Operations, Strategy, Regulatory Affairs , Market Access, and other key functions, to ... and making headway to help improve outcomes. The Medical Director for the Surgical Reconstruction (SR) Franchise will be...day-to-day running of, and leadership for, the Medical Science Liaison (MSL) team. This role works closely with key… more
- Gilead Sciences, Inc. (Foster City, CA)
- …information, please visit Gilead.com. We have an exciting opportunity within our US Medical Affairs (USMA) Liver team for a Director , Medical Affairs ... based in Foster City, CA. Reporting to the Senior Director US Medical Affairs (USMA) Liver -...projects. + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to lead… more
- Bureau of Alcohol, Tobacco, Firearms, and Explosives (Washington, DC)
- …Justice (DOJ) and similar organizations in other Government agencies. As the Assistant Director , Office of Public and Governmental Affairs , your typical work ... include: Initiates, formulates, executes, and coordinates the Bureau's public liaison activities. Provides supervision for the staff in the...the staff in the Office of Public and Governmental Affairs . Represents the Director and Deputy … more
