- Merck & Co. (Rahway, NJ)
- …chemistry, biopharmaceutics, material science, process development, and/or engineering and regulatory science.Proven ability to lead program development teams ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...bespoke, evidence-based M&A advisory services. Reporting into the Executive Director of M&A Advisory, the Director , M&A… more
- Insmed Incorporated (Bridgewater, NJ)
- …senior management regarding the potential impact of toxicology results on Program and Clinical/ Regulatory strategy.Author nonclinical sections in regulatory ... discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... plan, including data generations (including RWE), post-marketing research, medical education , research grants, medical advisory boards, and scientific communication/publication… more
- Merck & Co. (Millsboro, DE)
- … inspections (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This… more
- Merck & Co. (Rahway, NJ)
- …our Company's women's cancers, genitourinary (GU) and gastrointestinal (GI) cancer program ; heavy emphasis on milestone communications ( regulatory approvals, ... Job DescriptionPosition Description: Director , Global Oncology Communications The role of ...an in-office & remote). This position cannot be 100% remote. Education Minimum Requirements: Minimum of a BA required.Required Experience… more
- Merck & Co. (Rahway, NJ)
- …and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, ... functional groups in development, quality, safety, facilities management, analytical, finance and regulatory .-FLEx was designed to be a facility that evolves to meet… more
- Novo Nordisk Inc. (Chicago, IL)
- …and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory , biostats, data management, and other key stakeholder peer… more
- Merck & Co. (Rahway, NJ)
- …in some 150 markets.Accountable for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal Health Sites ... site, region and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance… more
- Insmed Incorporated (Bridgewater, NJ)
- …senior management regarding the potential impact of toxicology results on Program and Clinical/ Regulatory strategy.Author nonclinical sections in regulatory ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The ... position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance & Privacy Department's Government Accountability … more
- Insmed Incorporated (Bridgewater, NJ)
- …in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage ... in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA)Manage customized bioanalytical assays via network of external service providers in advance… more
- Merck & Co. (North Wales, PA)
- …System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), other worldwide ... to our partnership in support of the V940 Individualized Neoantigen Therapy (INT) program .Provide Quality leadership as part of the new Quality Platform to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical ... trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical...KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... successfully completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the ED will be responsible globally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the Brand team for ... ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary This position is responsible for the Sustainability program including setting strategy and implementation in the US for Daiichi Sankyo ... business practices.Responsibilities- Develop and manage the governance of a Sustainability program for the US affiliates to include necessary resourcing, proposing… more
