- Merck & Co. (Lower Gwynedd, 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
- Merck & Co. (North Wales, PA)
- Job DescriptionJob ScopeThe 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
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs ? The job is located in ... is a hybrid position. You will report to the Director of Global Regulatory Affairs . **Responsibilities:** You are a member of a Regional Therapeutic Area… more
- Merck (North Wales, PA)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process… more
- 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
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director - Dermatology in our Immunology Global Medical Affairs ... potential. At Johnson & Johnson, we all belong. The Global Medical Affairs Leader (GMAL), Director...Excellent knowledge of study execution, benefit risk management and regulatory affairs highly preferred + Proven ability… more
- J&J Family of Companies (Horsham, PA)
- Johnson and Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director - Gastroenterology within our Global Immunology Medical Affairs ... GMAL - Gastroenterology (GI), under direction of the Head Global Immunology Medical Affairs - Gastroenterology, is...execution, data analysis & review, benefit risk management and regulatory affairs is highly preferred + Highly… 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 (Prostate Cancer)** 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- CSL Behring (King Of Prussia, PA)
- …Regulatory TA Head. You will play an important leadership role as part of the Global Regulatory Affairs (GRA) GPS Leadership Team. You will lead the ... often rare conditions Could you be our next Senior Director , Regulatory Lead-Enabling Healthcare Technologies? The job...Strategy Team (PST), Clinical Development Team (CDT), and within Global Regulatory Affairs (GRA). **Experience**… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap. + Promotes regulatory ... shared goals. + Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
