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Collaborates with cross-functional teams, including operations, quality assurance, regulatory affairs, and finance, to align capital projects with business objectives and regulatory requirements.
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This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC, New Products, Sales & Marketing, and Legal. Prepare and present robust financial models to assess opportunities under evaluation; provide input on deal terms and creation of relevant clinical, regulatory, and commercial scenarios.
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Political Affairs Internship The role focuses on making poverty a focus of U.S., Canadian and U.K. foreign policy. Political Affairs Internship The role focuses on making poverty a focus of U.S., Canadian and U.K. foreign policy.
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Sr. Manager, Regulatory Science, CMC. Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. The Sr. Manager will provide regulatory support for Oncology.
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To be successful, you must work in collaboration with Regulatory Affairs, Marketing, Market Access, R&D, Professional Education, Sales Training, Global Commercial Teams, Enterprise, and other functional teams.
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Experience in medical affairs activities for Neurology products, specifically, Alzheimers. This role is for a Medical Director, a strategic role where you have control and oversight of medical affairs activities for Neurodegenerative disease products.
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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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Maintains expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
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Participate in all departmental training and development programs and others as designated by the Director of Residence Education, Assistant Vice President for Student Affairs or Vice President for Student Affairs.
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Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders, including but not limited to Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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Basic understanding of Life Sciences Commercial operations to include Field Sales, Medical Affairs, Market Access, Clinical Educators, and Engagement Center programs. The Client Engagement Manager applies Commercial operational services knowledge and project management processes obtained through education and experience to partner with Business Development and the Deployment Solutions leads to increase operational efficiencies and provide project support from the time an opportunity is officially pursued through hand-off to the Account Activation team.
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Note: An Engineer-In-Training (EIT) certification issued by the Division of Consumer Affairs, New Jersey Office of the Attorney General may be substituted for the above education requirement. The Engineer Trainee learns to recommend Electrical Materials for approval, approve traffic signal controller testing, and assist in the preparation of electrical plans and highway lighting designs for in-house design projects.
$62,088 - $64,482 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Leidos QTC Health Services is seeking qualified candidates for Medical Case Specialist I opportunities on our Veteran Affairs Operations team. As a Medical Case Specialist, you will work closely with veterans and the Veterans Administration to gather, collect, record, track and verify data and information from multiple sources.
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affairs job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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