- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders… more
- Insmed Incorporated (NJ)
- …values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive ... certification as a Great Place to Work® in the US , and a place on The Sunday Times Best...Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve… more
- Merck & Co. (Rahway, NJ)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- Coty (Morris Plains, NJ)
- Senior Manager, US Regulatory Affairs and...policy development and defense. This position reports to the Director , NA Regulatory Affairs and ... Ingredient Support **SENIOR MANAGER, US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking for smart leaders who are fast and passionate!** **We… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...vision. This position will report directly to the Executive Director of Medical Affairs . Together with the… more
- Genmab (NJ)
- …dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US Field Medical Affairs leadership team responsible for the execution of the ... Medical Affairs strategy in support of the US business objectives. The Director , HEOL Team...knowledge and adherence to corporate complianceCurrent working knowledge of US -specific legal, regulatory , and compliance regulations and… more
- Merck & Co. (Rahway, NJ)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Insmed Incorporated (NJ)
- …cross-functional partners, including ex- US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for...Affairs , and Commercial Effectiveness to ensure alignment of US HCP activities with field execution.Partner with Agency of… more
- Eisai, Inc (Nutley, NJ)
- …that drives optimal access and utilization of Eisai marketed products in the United States .Provide input to the health economics and outcomes research ... your profile, we want to hear from you. The Director , US HEOR and RWE (field) is...the employment eligibility of all new hires in the United States . Please click on the following… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree in a related field is preferred 10+ years of experience in pharmaceutical, regulatory affairs , or compliance roles, with a strong background in patient ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib program in HS ... Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …governance meetings Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs , IT, and Global Units Manage change initiatives ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global ... Medical and Scientific Affairs as well as Outcomes Research.Under the guidance of...development of American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers for use by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and enhance our reputation with patients, customers, employees and society in the US . Communications is comprised of four distinct yet synergistic teams that work ... work together to change lives for the better. The Position The Associate Director , Media Relations & Issues Management is accountable for establishing and leading… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Organon & Co. (Jersey City, NJ)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Create job-specific training curricula for different roles within clinical operations, medical affairs , and regulatory affairs Maintain training assignments ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our...years of experience in pharmaceutical training, clinical research, or regulatory affairs Strong knowledge of clinical research… more
