- Novo Nordisk Inc. (Plainsboro, NJ)
- …of any required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress. Additionally, fellows may be… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas during their rotations. Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, ... Essential Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc. This structured… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education throughout the one-year program. Additional key internal relationships include Medical Affairs , Marketing, Legal and Regulatory Affairs . Other ... internal relationships include managed care, trade, government affairs and global marketing.External relationships include relations with key opinion leaders,… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- … regulatory compliance and technical feasibility of proposed changes.Serve as project manager for the change process and provide coordination to ... coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US … more
- Philips (Hamilton, NJ)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... lives of patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product… 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
- 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...meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders + Write Regulatory documents translating… more
- Haleon (Warren, NJ)
- …Care to join us. It isn't a question. **About the role** The **Senior Manager , US Regulatory Affairs -Wellness** is responsible for end-to-end regulatory ... **Problem Solving** + This role will independently sit on project teams. The regulatory environment for dietary...Science Biology, Chemistry) + 7+ years of experience with Regulatory Affairs + 5+ years working specifically… 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 ... will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress. + Additionally, fellows may be… 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: ... Company located in NJ is hiring a Global Medical Affairs Project Manager 3+ years...ability to manage multiple projects simultaneously + Familiarity with regulatory requirements + Excellent communication and interpersonal skills, with… more
- Clearway Energy (Princeton, NJ)
- ** Manager , External Affairs - East Region**...team works at the interface of public policy and project development to advance legislative and regulatory ... development pipeline and operating fleet. This role will lead Clearway's external affairs engagement in Eastern states, with an immediate focus on New England,… more
