- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...resolution. + Participate in global product team meetings to provide US … more
- Stryker (Mahwah, NJ)
- …The ** Director , Global Clinical Evidence and Medical ... and support from division Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior...partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. + Responsible… more
- AbbVie (Florham Park, NJ)
- …understanding of relevant therapeutic area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. + ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Bristol Myers Squibb (Madison, NJ)
- …as appropriate. **Key Responsibilities** + Support development and execution of the US Medical Affairs plans, in coordination with the Global Medical Affairs ... work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical, Multiple Myeloma will report to the Director ,… more
- AbbVie (Florham Park, NJ)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …your best self. Become a **maker** **of possible** with us. As the Medical Affairs Director of Innovation you will be responsible for leading efforts related ... to Medical Affairs innovation. You will be a member of a...pediatrics, cancer, diabetics) would be advantageous + Understanding of global regulatory requirements and guidelines for the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- System One (Florham Park, NJ)
- …within the team. + Work closely with cross-functional teams, including medical affairs , clinical operations, regulatory affairs , commercial and marketing, ... Job Title: Director /Senior Director , Medical Operational Excellence Lead...Lead Full time permanent position - Direct with a global pharmaceutical company Location: North NJ Hybrid Role -… more
- Bristol Myers Squibb (Madison, NJ)
- …leaders, key professional societies, and organizations in collaboration with other global medical affairs functions and clinical colleagues through scientific ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Senior Director , WW Medical Neuropsychiatry Strategy** **Location: Princeton Pike or… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + ... **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring...BD while informing the broader scientific strategy with Medical Affairs . This role is accountable for de-risking the new… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** + The Director ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more