- Takeda Pharmaceuticals (Trenton, NJ)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Sumitomo Pharma (Trenton, NJ)
- …, Regulatory Affairs ** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is expected to ... input as appropriate + Maintains development and post-marketing regulatory compliance by conducting global regulatory...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs The base salary range for… more
- Merck (Trenton, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... Support device design control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products,… more
- Merck (West Point, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Sumitomo Pharma (Trenton, NJ)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...member of the Medical Affairs team reporting to the Executive Director ,… more
- Sumitomo Pharma (Trenton, NJ)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
- Merck (West Point, PA)
- **Job Description** **Job Scope** The Director , Corporate Affairs and Patient Innovation & Engagement Compliance has global compliance responsibility for all ... areas of Corporate Affairs , including Global Communications, Global and Regional Public Policy,...Research and Development Division's Value & Implementation organization. The Director serves as a dedicated global business… more
- Sumitomo Pharma (Trenton, NJ)
- …, Medical Strategy (Women's Health) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- Sumitomo Pharma (Trenton, NJ)
- …. **Job Overview** Director , Field Medical and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner.… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …Lead will provide clinical development support and guidance into global regulatory interactions, will assist the Medical Affairs team, as necessary, and ... Senior Director , Clinical Development - Neurology **Date:** Jan 8,...internally as clinical development expert for global regulatory interactions; collaborate with Regulatory Affairs… 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 ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key… more
- Edwards Lifesciences (Trenton, NJ)
- …healthier lives. Join us and be part of our inspiring journey. As the ** Director , Clinical Affairs (Clinical Data & Evidence Strategy),** you will be responsible ... portfolio. Support business growth and collaborate with stakeholders in Medical Affairs (including scientific communications) Global Health Economics and… more
- Merck (West Point, PA)
- …Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D and ... and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards. Product managers must possess… more
- Merck (West Point, PA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …and associated regulations is required + In-depth knowledge of Quality Assurance and Regulatory Affairs as applicable to the Pharmaceutical industry is preferred ... **Quality Systems Manager** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to… more
- Edwards Lifesciences (Trenton, NJ)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more