- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy ... to be a part of our Global Regulatory Affairs organization.In this role, you will work in...of the Company Core Data Sheep and US Prescribing Information . Responsible for maintenance of the IND. Monitor and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... Core Data Sheet, USPI, EU SmPC and related patient information ) for the Genmab portfolio of products. This role...portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that ... Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with colleagues within Patient Support Programs, Patient… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… more
- Genmab (Plainsboro, NJ)
- …in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- ... status, or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity Employment laws,… more
- Merck & Co. (Rahway, NJ)
- …breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Global Pharma Communications is responsible for leading, developing and executing US and global communications strategies and ... infectious diseases, neuroscience, ophthalmology, and immunology. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Director in the CCFS group and working in conjunction...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely and ... agencies inquiries and other reporting requirements are met. Provides information to other internal departments where deemed appropriate.Develop project plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,...E- Work with the business users to define user information needs, research innovative product value proposition, and collect… more
- Merck & Co. (Rahway, NJ)
- …the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics, ... 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
