- Sanofi (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... Job Title: Development Scientific Director (DSD) Location: Cambridge, MA, About the Job...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… more
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. The Senior Director of Gene Therapy Medical Affairs will work across our gene ... with internal business partners including clinical teams, commercial teams, legal, regulatory affairs , ethics and compliance, and other relevant functions.… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Role Overview** The Sr. Director , Clinical Development is an experienced clinical trialist who will be responsible ... into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / scientific support… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and...is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will… more
- CSL Behring (King Of Prussia, PA)
- As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support the assigned US ... leaders in relevant fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial +… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Partner across Kite Medical Affairs , Clinical Development, Translational Medicine, Regulatory Affairs , and Product Teams to build integrated cross-functional ... Kite and help create more tomorrows. **Job Description** The US Medical Senior Director , MA Evidence Generation at Kite Pharma, a Gilead Company, will provide… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing strategies, WHO ... Senior Program Officer, you will report to the Deputy Director of Regulatory Strategy and Product Support....other foundation operational resources. + Experience in health product regulatory affairs , from research and clinical development… more
- CSL Behring (Waltham, MA)
- …CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director , Corporate & External Affairs , R&D Portfolio **Main ... **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager,...Responsibilities and Accountabilities:** + Support the Associate Director in serving as a business partner and advisor… more
- Lilly (Boston, MA)
- …being accountable for submissions, and taking part in meetings. + Represent the regulatory affairs team on cross-functional project teams and provide guidance to ... is headquartered in Boston, Massachusetts. **The Position** The purpose of the Associate Director , Regulatory Strategy role is to support the development and… more
- CSL Behring (King Of Prussia, PA)
- The Director , Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The ... which at least 7 years of experience in Medical Affairs or other market facing organizations **Competencies** + Demonstrated...+ Ability to think out of the box of regulatory requirements + Familiar with causal inference based on… more
- CSL Behring (King Of Prussia, PA)
- …**Qualifications & Experience Requirements** Bachelor's degree required. *8+ years of Regulatory Affairs experience, with at least 6+ years specifically ... therapies that make a meaningful difference worldwide. Could you be our next Director , Global Advertising and Promotion? The job is in our King of Prussia,… more
- Sanofi Group (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...experience in ophthalmology + Knowledge of drug development, ocular gene therapy, regulatory strategy + Good networking… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical to the success… more
- Fujifilm (College Station, TX)
- …Collaboration** : Work closely with the Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and ensure ... **Position Overview** As the Associate Director of Microbiology, you will play a pivotal...a contamination-free environment, support our product pipeline, and ensure regulatory compliance. **Company Overview** The work we do at… more
- CSL Behring (King Of Prussia, PA)
- …cross-functional collaboration across the enterprise. Under the guidance of the Publications Director , you will partner with Medical Affairs leaders, Compliance, ... trackers, SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication metrics and… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director , Commercial Data Science & AI is crucial in driving the overall strategy for (Gen)AI tools and technologies within CSL. This individual will ... role you will be reporting in to the Senior Director of Commercial Business Analytics Reporting & Data Science....use cases) In close partnership with ABCIA Commercial, Medical Affairs , and Market Access teams to ensure solutions are… more
- CSL Behring (King Of Prussia, PA)
- …data collection and submit all reports needed for compliance. 4. Work with Senior Director , Policy Advocacy & Government Affairs , & Legal to interpret and ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more
- University of Colorado (Aurora, CO)
- …trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are ... fit for use. + Performs review of cell and gene therapy product files and sponsor protocols, ensuring accurate...- four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory.… more
- Sumitomo Pharma (St. Paul, MN)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of… more
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