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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group.
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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This incumbent will have responsibility for OSHA and any other EHS related regulatory compliance, injury prevention programs, environmental compliance such as EMS (Environmental Management Systems) and any other environmental related regulatory compliance, injury case management (i.e. working knowledge of injury claims), site security, technical safety advice and have the ability to educate others on safety in a very diverse work environment.
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Develop and implement strategic MSL field/territory plans and objectives in alignment with Medical Affairs and product strategy and oversee the successful execution of these plans. Connect with appropriate internal stakeholders to ensure strategic and tactical alignment of the MSL team both within the wider Medical Affairs organization and with other Company departments.
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Director, NA Oncology MSL Team is a field-based position within the Medical Affairs Department. Develop MSL-appropriate goals and objectives and assess processes to track performance and report metrics to the Medical Affairs leadership team.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Ensures appropriate controls are in place to meet regulatory requirements (i.e. J-sox, Third Party Risk Management, etc.) Ensure the adoption and enforcement of all flexible workforce policies, which includes, working closely with Legal Affairs and other internal stakeholders.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The Associate Director will work closely with cross-functional project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program.
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regulatory affairs jobs Title: regulatory project manager Company: Gpac in Lawrence, NJ
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