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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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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$170,625 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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In this capacity the Associate Director, Economic Modeling, will design and deliver rigorous economic modelling analytics that address business questions, and will champion best in class modeling methodology within Scientific Evidence & Policy Research (SEPR) at Scientific Affairs.
$135,000 - $232,300 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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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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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 Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy.
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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.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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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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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.
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Call on and secure relationships with senior leadership in Epidemiology, Primary and Secondary Research, Medical Affairs, Value and Evidence, HEOR, Marketing, Brand Management, Product Management, Managed Markets, Market Access, Data Analytics, and other areas within organizations.
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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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Also, interacts routinely with colleagues across Market Access and Public Affairs, and internal stakeholders from Marketing, Medical Affairs, HEOR, Finance, Commercial, Field Sales, Government Pricing, and other relevant departments.
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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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