- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for ... research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory... lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states … more
- Merck & Co. (North Wales, PA)
- …of others. -Who we are - - We are known as Merck & Co., Inc., in the United States and Canada and MSD everywhere else. For more than a century, we have been ... us -and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders...arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …BD&L. Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs , analytics, and other relevant NNI departments ... . Work collaboratively with cross-functional teams including research and development, regulatory affairs , and commercial teams, to align product development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...us ? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This ... continuous learning and personal development. Are you ready to maximize your potential with us ? The Position The Director, CMR Insights Lead is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), 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 Consumer Strategy Lead … 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 Brand Strategy Lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements ... Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience requiredExperience with ... of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …driving value through human-centered design pull you in? Are you ready to experiment with us ? The Position The HCP Experience Lead will play a critical role in ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … US Competitive Intelligence, Managed Markets, Clinical Insights, Medical Affairs , Scientific Center of Excellence) and externally (eg, KOL interviews, literature ... About the Department The Clinical Development, 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 (Bridgewater, NJ)
- …and represent content during medical, legal, regulatory reviewWith Medical Excellence, lead training of Medical Affairs teams on new materials and upcoming ... and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed… more
