- AbbVie (Florham Park, NJ)
- …and provide strategic counsel to senior leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline ... in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative...to contribute as a key member of disease area strategy teams responsible for long-term R&D and innovation strategies.… more
- Bristol Myers Squibb (Princeton, NJ)
- …leading strategic diagnostic initiatives that support BMS's Precision Medicine strategy . This includes identifying and evaluating emerging diagnostic technologies ... solutions. The role oversees diagnostic development from concept through regulatory approval and commercialization, manages strategic alliances, and ensures… more
- J&J Family of Companies (Raritan, NJ)
- …point of contact to ensure quality of the GxP system, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. ... for Clinical Business Units and R&D functions, ensuring quality and regulatory compliance within the organization. **Key Responsibilities:** + Collaborate with… more
- Sumitomo Pharma (Trenton, NJ)
- …Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …partners. **Key Responsibilities:** + Develop and implement the overall MSAT strategy supporting the company's portfolio, focusing on technical oversight of CDMO ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Sumitomo Pharma (Trenton, NJ)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... matter expert for advanced analytics across the Commercial Analytics & Field Strategy function. **Essential Skills and Abilities:** + Ability to extract actionable… more
- Sumitomo Pharma (Jersey City, NJ)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... investigator-sponsored studies intended to support the clinical and scientific strategy of the Company's products. + Help develop and...- 3 years of relevant experience in biotech or pharmaceutical industry + 1-3 years of MSL experience in… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …and other provider networks. The person will direct the pricing and reimbursement strategy for new launches and in-line products, own the tactical execution of the ... The role will report to the Head of Commercial Strategy , Pricing and Analytics. The ideal candidate will have...and approval process working closely with government pricing and regulatory teams. + Work closely with the finance team… more
- Publicis Groupe (Morristown, NJ)
- …and regulatory requirements + Prepare and submit jobs for pharmaceutical medical, legal and regulatory review **Qualifications** **Skills:** + Ability ... in developing specific expertise in communications, analytics, market research, strategy consulting or software development / support. **Responsibilities** + Manage… more
- Sanofi Group (Morristown, NJ)
- …different steps of clinical development, integrating into to the overall development strategy in collaboration with the responsible Therapeutic Area in research and ... manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines;… more