- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Merck & Co. (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the ... of the Head of Quality / Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- J&J Family of Companies (Raritan, NJ)
- …of Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in ... Johnson & Johnson Innovative Medicine is recruiting for Associate Director, RA Submissions. The position can be... regulatory affairs , submission management, or a related… more
- Merck (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data ... range of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals. **Key… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... design efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E - Work with the… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director, Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... of patients around the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty Care Communications team to support… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Consumer Marketing - US Rare Hematology **Location** : Cambridge, MA **_About the Job_** This role will drive consumer marketing ... include, HCP marketing, Global Marketing, Sales, Research & Development, Medical Affairs , Business Development, Market Research, Life Cycle Management and Finance… more
- Sanofi Group (Morristown, NJ)
- …+ **Cross-Functional Collaboration** - Collaborate with internal stakeholders (R&D, regulatory , safety, medical affairs , commercial) to drive switch-related ... global medical strategies for Rx-to-OTC switch programs, collaborating with science, regulatory , and commercial teams to ensure alignment. + **External Expert… more
- J&J Family of Companies (Raritan, NJ)
- …This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior Local Trial ... is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical… more
- Merck (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Hackensack Meridian Health (Edison, NJ)
- …compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries ... as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products. ... areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities… more
