- Novo Nordisk (Princeton, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Philips (Hamilton, NJ)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC ... entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory … more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager /Personal Care Princeton, NJ, US Hybrid Are you passionate about the cosmetic and OTC sunscreen regulations in North America with a ... customer centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America (NA), you will be part of a cross-functional team located in… more
- Novo Nordisk (Plainsboro, NJ)
- …required documents to FDA. Relationships The fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... Are you ready to make a difference? The Position The Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- Abbott (Princeton, NJ)
- …scientific dissemination of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global ... of ad promo materials or other assets which require medical/legal/ regulatory review + Organization & moderation of periodic Medical...Leadership Team + Supporting the Director of Global Scientific Affairs , in conjunction with the Sr. Manager … more
- System One (Raritan, NJ)
- Title: Global Medical Affairs Project Manager Location: Must be local Raritan, NJ and required to go onsite 2 days a week onsite Type: Embedded Start Date: ASAP ... Leading Pharmaceutical Company located in NJ is hiring a Global Medical Affairs Project Manager 3+ years industry experience. If you want to be a part of this… more
- Novo Nordisk (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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Ascendis Pharma (Princeton, NJ)
- …Medical - Endocrine Medical Affairs will report to the US General Manager with primary responsibility to lead the US Medical Directors and ensure the compliant ... Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs... Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC, Graphics, Legal, Quality, Supply ... labeling for accuracy and for other regulatory requirements. + Liaise with Regulatory Affairs members and other cross-functional teams to ensure the accuracy… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Aug 27, 2024 Req ID: 3739 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs ... we go next!** **_Advancing healthcare with heart_** **Job Summary** Senior Manager , Clinical Advisor is responsible for developing and implementing the clinical… more
- J&J Family of Companies (Titusville, NJ)
- …medical affairs including collaborating closely with compliance, privacy, and regulatory partners + Build scalable analytics solutions in partnership with Data ... Manager , AI for Medical Engagement - 2406194669W **Description**..., AI for Medical Engagement** to support the medical affairs organization. This position will be located in Horsham,… more
- Novo Nordisk (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
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… more
- Sanofi Group (Bridgewater, NJ)
- …health systems solutions, market access, business operations, finance, medical affairs , regulatory , legal, compliance, global marketing, training, portfolio ... **Senior Product Manager , Flu Franchise Marketing** **Location- Bridgewater, NJ** **About...Veeva Promomats. + Ensure all promotional materials adhere to regulatory guidelines and compliance standards. **Promotional Material Review Management:**… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... dynamic, highly motivated, and experienced individual for the position of ** Manager , Pharmacovigilance Scientist.** The Manager , Pharmacovigilance Scientist will… more