- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a ... the US regulatory submission strategy For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented… more
- Genmab (Plainsboro, NJ)
- …(in line with Target Product Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented ... to regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs Develop and implement knowledge management technology ... existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve… more
- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Tris Pharma (Monmouth Junction, NJ)
- … compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information ... opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is...data and information to ensure highest ethical standards and compliance with law, regulations, guidelines and policies Assists VP,… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... financial milestones and related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare compliance ... is preferred A minimum of eight (8) years combined pharmaceutical, human resources, legal, regulatory , and compliance experience required OR a minimum of six (6)… more
- Merck & Co. (Rahway, NJ)
- … Director will manage key challenges, including supplier relationship management , risk mitigation through robust business continuity plans, and responding to ... Job DescriptionThe Executive Director for the Integrated Logistics Procurement & Sourcing...Evaluate and enhance logistics and procurement processes to ensure compliance with regulatory requirements and industry best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …against contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management : Demonstrate ... marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... Vice President, Human Health and Manufacturing Communications, the Executive Director , Vaccines Communications is responsible for the development of strategic… more
- Merck & Co. (Rahway, NJ)
- …We are seeking a talented individual to join the team as Global Marketing Director to focus on expanding and growing our product, the first-and-only HIF2 inhibitor, ... disease and alliance teams, research and development, medical affairs, regulatory affairs, market access, outcomes research, manufacturing, market analytics,… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Associate Principal Scientist/Associate Director , Outcomes ResearchRole SummaryUnder the guidance of a senior leader, an Associate Principal ... Scientist/Associate Director , has primary responsibility for planning/managing real world and...reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical...and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology,… more
