- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...review teams and partner companies, reinforcing the use and implementation of labeling best practices. Assist or lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...review teams and partner companies, reinforcing the use and implementation of labeling best practices. Assist or lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and ... to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to assess commercial viability of potential drugs. + Provides Regulatory Implementation Risk Assessment and mitigation strategy during various phases of ... on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to… more
- Sanofi Group (Bridgewater, NJ)
- …experience partnering with cross-functional teams is strongly preferred (eg, Medical, Regulatory Affairs , Market Access, Communications). + This position may ... **Job title** : Global Public Affairs Head, Hemophilia **Location:** Cambridge, MA **Additional Locations:**...on in-line (Altuviiio) and pipeline (fitusiran) assets. + Drive implementation of a robust Global PA strategy … more
- Bausch Health (Bridgewater, NJ)
- …be responsible for building top-notch HEOR capabilities and implementing an HEOR strategy that is integrated and aligned with Product Development Plans (PDPs) and ... and product-based strategic leadership that supports HTA/Value data needs, ensuring implementation through inclusion in PDPs and CDPs, and ultimately Brand Plans.… more
- Veterans Affairs, Veterans Health Administration (Kings County, NY)
- …affordable, and equitable patient care. Ensures compliance with accreditation and regulatory standards. Fosters a safe and supportive environment conducive to the ... Aligns nursing/clinical objectives with organizational strategic outcomes, participating in strategy planning and execution. Provides peers with informal constructive… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …responsibilities include providing strategic recommendations to senior leadership and overseeing strategy implementation with the Payer & Trade Accounts. ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Pfizer (New York, NY)
- …to have a thorough understanding of the processes associated with Medical Affairs . Working knowledge of lifecycle management and regulatory processes is ... **Join Our Visionary Team within Pfizer's US Medical Affairs !** Are you passionate about pioneering science and...leading the US Medical team comprised of Brand Medical Strategy teams across IM therapeutic areas and will partner… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …overall, RA strategy . + Leads the requirement identification, design, implementation , and continuous improvement of the BDX Regulatory Information Management ... **Job Description Summary** As Senior Manager of Regulatory Affairs Systems and Operations, you...Operations, you will be responsible for overseeing the development, implementation , and maintenance of the global BDX Regulatory… more
- Pfizer (New York, NY)
- **Join Our Visionary Team within Pfizer's US Medical Affairs !** Are you passionate about pioneering science and transforming healthcare? In US Medical Affairs , ... teams medical strategies and activities are fully aligned with US Brand Medical Affairs and related business partner priorities across SC and IM priority therapeutic… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …guide product strategy -- Including cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + Interact ... for priority products in development at BD while informing the broader scientific strategy with Medical Affairs . **Job Description** We are **the makers of… more
- Kedrion Biopharma (Fort Lee, NJ)
- …+ In-depth knowledge of US pharmaceutical market which includes experience working with regulatory affairs , medical affairs , finance, and promotional review ... Responsibilities: **Brand Marketing and Product Management:** + Owns the development, implementation and execution of robust brand strategy , product positioning,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …1 and phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both local and international, related to the clinical ... stages of development. + Collaborate with KOLs as needed to for clinical/ regulatory strategy , Health Authority Advisory meetings, development of target… more
- Bristol Myers Squibb (Summit, NJ)
- …are completed + Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality ... careers.bms.com/working-with-us . **Position Summary** The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...review teams and partner companies, reinforcing the use and implementation of labeling best practices. Assist or lead the… more
- Sanofi Group (Morristown, NJ)
- …expectations of the Regulatory Authorities, in coordination with CHC US Regulatory Affairs , lead/co-lead the support of Health Authorities in their ... regulatory requirements. Also, partner closely/hand-in-hand with the Industrial Affairs Quality Team at the Chattanooga manufacturing & development site. Opella,… more
- Sanofi Group (Bridgewater, NJ)
- …into the Global Medical Immunology team that is part of the Medical Affairs Specialty Care organization. Our Medical function serves as a key strategic partner ... with commercial, regulatory , clinical, and market access on therapeutic solutions to...solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and ... to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and… more
