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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott Point of Care.
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The MSL/Sr. MSL is a member of a field-based team of advanced degree specialists who function as an extension of the Global Medical Affairs organization. Genmab is currently seeking a Hematology Medical Science Liaison (MSL)/Senior MSL to be a part of an exciting opportunity of a passionate, high profile, high-impact Global Medical Affairs team, and work in a dynamic and collaborative setting.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Work with CMC cross-functional teams and Regulatory Affairs teams. Requirements: BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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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) Director, Regulatory Affairs Strategy Apply locations Princeton, NJ time type Full time posted on Posted 3 Days Ago job requisition id R10256.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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Knowledge of Bank Secrecy Act regulatory requirements, including CTRs and SARs, and basic knowledge of banking regulations. BSA Analyst responsibilities include: Administering the Bank Secrecy Act/Anti-Money Laundering Program and related procedures in accordance with Bank’s policies, procedures, and applicable federal regulations.
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They will coordinate with other TA functions including Medical Directors, Alignment Director, Program Development Director, and the Medical Liaison field team both within TA and across other TAs. This position will also coordinate with key functions across CMR (e.g., NACO), Public and Government Affairs, and commercial.
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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The Director, IP Counsel will report to the Senior Director, IP Counsel in the Intellectual Property Practice Group in Legal Affairs. Develop and communicate IP guidance to stakeholders across the business, including within Clinical Development, Medical Affairs, Business Development, Commercial, Marketing, and Legal Affairs.
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Collaborate with the head of NA HEOR and cross-functional teams, including members of medical affairs, clinical development, regulatory, market access, and commercial. Collaborate with the head of NA HEOR and cross-functional teams, including members of medical affairs, clinical development, regulatory, market access, and commercial.
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regulatory affairs jobs Title: sr associate Company: Thermo Fisher Scientific in Lawrence, NJ
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