- Sumitomo Pharma (Trenton, NJ)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...collaboration with the Clinical Research Team. + Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient… more
- Sanofi Group (Morristown, NJ)
- …technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded ... This critical role: + Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI to launch, and… more
- Gilead Sciences, Inc. (Jersey City, NJ)
- …+ ** Compliance and Ethical Leadership** : Deep understanding of pharmaceutical sales regulations and compliance requirements, committed to fostering a ... + Demonstrate a deep understanding of industry trends, competitive landscape, and regulatory environment. Use this knowledge to guide the team and make informed… more
- Sanofi Group (Morristown, NJ)
- …Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory ... sharing information and answering questions based on approved material within Regulatory guidelines. + Engages with appropriate stakeholders to understand the state… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …cost of doing business while maintaining/improving quality and adherence to regulatory guidelines. **Key Responsibilities:** + **Strategic Oversight:** + Develop and ... in key R&D functions (Clinical Management, Data Management, Global Pharmacovigilance, Regulatory Affairs, Asset Management), and Shared Services (Finance, Legal, and… more
- AbbVie (Florham Park, NJ)
- …scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight ... activities with internal stakeholders (ie, commercial, clinical operations, discovery, statistics, regulatory , etc ) as they relate to on-going medical affairs… more
- Sumitomo Pharma (Trenton, NJ)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...critical role in supporting the tax department in meeting compliance , provision, and planning goals. The position is primarily… more
- Bausch + Lomb (Bridgewater, NJ)
- …scalable and adaptable to the evolving needs of patients, healthcare providers, and regulatory environments. ** Compliance & Best Practices:** + Ensure that all ... in managing large-scale, multi-faceted patient support programs. + Familiarity with regulatory requirements specific to pharmaceutical patient support programs,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …medical device, digital health, and AI clients on the application of healthcare regulatory laws to their business. The position will report to the Executive ... inside and outside the department. All members of OPH Legal and Compliance must exemplify collaborative culture and drive joint accountabilities across multiple… more
- Sumitomo Pharma (Trenton, NJ)
- …in biotech or pharmaceutical drug development. + Experience in interaction with regulatory agencies such as the FDA, EMA/CPMP, PMDA, or others. + Experience in ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
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