- Tris Pharma (Monmouth Junction, NJ)
- …marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations , etc.)Collaborates closely with Analytics team ... Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key internal relationships include global and US stakeholders in other areas of Regulatory Affairs , as well as those who are part of the promotional review ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our...Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations , Pharmaceutical Technology ... CMC regulatory compliance activities for portfolio biologics to meet US , International Conference on Harmonization (ICH), and other applicable regulations. This… more
- Merck & Co. (North Wales, PA)
- …of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices ... regulatory consultation in the development and implementation of US marketing strategy and promotional programsSupport the US...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Upper Gwynedd, PA)
- …edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical Affairs … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs , Data Management, Biostatistics, Non-clinical, ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...strategy, major safety deliverables for assigned programs within the US East Coast Development Hub portfolio in close collaboration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Affairs interests on cross-functional teams including, Field Medical Affairs , Medical Operations , Clinical Trial Management, HEOR, Market Access, ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs , Data Management, Biostatistics, Non-clinical, ... human health starts here and that patients rely on us . Our R&D hub merges biotech speed and agility...Safety Surveillance and other cross functional teams. Oversees daily operations of the function by directing staff and adhering… more
- Merck & Co. (Rahway, NJ)
- …assay development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of ... your employment may pose an undue burden to business operations , in which case you may not be offered...in certain states and cities within the United States . Final determinations with respect to… more
- Insmed Incorporated (San Diego, CA)
- …ophthalmology clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs , commercial, pharmacovigilance, ... 2024, we became Great Place to Work-certified in the US for the fourth year in a row. We...to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs , R&D, and Legal) and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts as ... the primary legal advisor for the commercial business and operations supporting US approved (or to be...US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...pull you in? Are you ready to experiment with us ? The Position The therapeutic area Operations … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience requiredExperience with ... More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Disease Marketing, Field Sales, CI&A, Field Force Execution, Marketing Operations , and Legal/Medical/ Regulatory PRB reviewers. External relationships include ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Merck & Co. (North Wales, PA)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standardsCommercial lead in driving engaging presence of… more
- Merck & Co. (Rahway, NJ)
- …stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality, Operations , Product Development groups, Regulatory Affairs , ... to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …oversight and decision-making. Coordinate cross-functional collaboration among commercial teams, medical affairs , regulatory affairs , and other stakeholders ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...pull you in? Are you ready to experiment with us ? The Position The Portfolio Operations Specialist… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government Affairs & US Corp Giving & Social ... learning and personal development. Are you ready to maximize your potential with us ? The Position Responsible for managing day-to-day operations of pharmacy… more
