- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs ...area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit… more
- Merck & Co. (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …program and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...& evidence team and other relevant functions As a senior level representative of medical affairs , the… more
- Aequor (Thousand Oaks, CA)
- …supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research, ... FULLY REMOTE Regulatory Writing Senior Manager ln this...following applicable standard operating procedures With limited supervision, lead regulatory writing activities for complex product submissions,… more
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Merck & Co. (Rahway, NJ)
- …The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... Their role is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial division, ensuring compliance… more
- Merck & Co. (North Wales, PA)
- …review and submit PQC reports and provide PQC data /line listings to US Regulatory Affairs for inclusion in Drug Experience Reports to be submitted to ... Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports...Manufacturing groups and associated functional areas related to the Product Quality Complaint (PQC) system. They also support the… more
- Merck & Co. (North Wales, PA)
- …and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Catalent (San Diego, CA)
- …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Eisai, Inc (Nutley, NJ)
- …Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area leads ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Arthrex (Naples, FL)
- …Arthrex is actively searching for a Sr. Project Manager, Program Manager - Regulatory Affairs who is responsible for managing and resolving issues related ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs . Develops project objectives by reviewing project proposals… more
- Tris Pharma (Monmouth Junction, NJ)
- …and other strategic initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New ... International patents including applications and several brand and generic product approvals in the US and globally. We have...opening in our Monmouth Junction, NJ facility for a Senior Manager, Business Development.The primary role of the … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …experience in pharmaceutical / biotech / CDMO industry Quality Assurance and Regulatory Affairs required10+ years of progressive people leadership and workforce ... matter expert on GxP compliance. He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and Exela on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... the Brand team for Insmed's in-line rare disease respiratory product and will be responsible for the development and...of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does… more
