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Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management.
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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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The Director of Policy and Regulatory Affairs will be responsible for managing Elevate’s relationships and policy positions at PJM, federal and state regulatory agencies, and state legislative bodies.
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Utilizes software systems, including Medicat, PeopleSoft, a BASICS Feedback Survey tool, and Microsoft Outlook and Excel, to manage referrals to and from BASICS as well as scheduling and the online assessment students complete as part of BASICSCollaborates closely with colleagues across University Health Services and from across campus, including the Office of the Dean of Undergraduate Students and Graduate Student Affairs, to receive referrals and educate campus partners about BASICS.
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Lead through Internal Collaboration : Forge strong collaborations with clinical development, medical affairs, market access, and regulatory teams to ensure seamless integration of Access strategies into overall product development and market access plans Lead in External Agency Management : Provide hands-on oversight and guidance on HEOR and pricing related agency selection and management, ensuring the highest quality of collaborations at proper cost.
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Relationships This position reports directly to the Executive Director, Medical Affairs and will assist the Executive Director and Sr. Director (where applicable) in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal relationships include Field Medical Affairs, Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and Market Access.
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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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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.
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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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Assist the Clinical Program Director, Program Supervisor and Lead Housing Specialist in communicating with the Department of Community Affairs and HUD with Project Managers for COC vouchers for chronically homeless individuals in Mercer County.
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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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Reports to HCP Strategy Lead. Collaborates with cross-functional teams, including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, and other relevant NNI departments to ensure alignment of HCP brand objectives and strategies, effective execution of HCP experience strategies and transparent communications outside the department.
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RELATIONSHIPSThis position reports to a Director Level Team Member within Scientific Communications (SC), Medical Affairs. The Manager-Publications is expected to develop and utilize a network of internal relationships with local and global publication stakeholders, including colleagues from Medical Affairs, Clinical Data Science & Evidence, legal, regulatory affairs, global publication team, and commercial publications colleagues from market access and marketing.
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Collaborating with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources and according to developed timelines. 10+ years experience in pharmaceutical industry Medical Affairs specifically.
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They will partner with US and WW Commercial, Research and Development , HEOR and Regulatory Affairs to support NULOJIX, SPYRCEL, ABRAXANE and other Established Brands. + The ideal candidate will have clinical expertise or some relevant experience in the disease area, such as within Medical Affairs or Clinical Development; experience in immunology and kidney transplant highly desirable.
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affairs job Title: sr affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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