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Develop strong and close working relationships with key Gilead markets (G9) and cross-functional partners (Medical Affairs, Global Decision Sciences and Insights, Public Affairs, Government Affairs, Value and Access, Clinical Development, Competitive Intelligence, Legal, and Regulatory Affairs.
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Position Title: Senior Regulatory Affairs Associate, New Product Development. In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products and claims in labeling.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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CERTIFICATES, LICENSES, REGISTRATIONSAPICS Certification preferred; CFPIM and CSCP are highly desirablePERSONAL PROTECTIVE EQUIPMENTSafety Glasses, Safety Shoes or Protective Slip-ons when in warehouse or plantAbout Thermo Fisher Scientific Our Mission is to enable our customers to make the world healthier, cleaner and safer.
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You will collaborate with Medical Affairs Technology and Medical Excellence personnel, Legal and Regulatory personnel, and Medical Affairs colleagues to evolve our content oversight, management, and CRM platforms to enable an efficient review and approval of materials, ensure the proper storage and fulfillment of materials, and track how our medical content is used externally.
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Serve a primary liaison to provost office faculty affairs, payroll, and HR benefits regarding H&S faculty PS records. Reporting to the Assistant Dean for Faculty Affairs, the Faculty Affairs Officer/Staff Associate will be responsible for a wide range of activities related to the faculty life cycle processes and support of faculty in general within the School of Humanities and Sciences.
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Serve as USMA Head of Liver and COVID-19 at cross-functional meetings, representing the US perspective and needs in working groups with respective Clinical Development, Global Medical Affairs, US Commercial, US Government Affairs and Policy, US Public Affairs, US Regulatory, and US legal and compliance.
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Our customers include the Department of Veterans Affairs, Department of the Air Force, NASA, Department of the Treasury, General Services Administration, SLAC, Stanford University, US Coast Guard, and Defense Logistics Agency.
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Office of the Vice Provost for Student Affairs. Promotes contribution to the Stanford Digital Repository (SDR), provides assistance in depositing materials into the SDR, and serves as a liaison between the School of Engineering, DLSS and the Scientific Data Librarian.
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Collaborate with and integrate deliverables across functional teams - from product marketing, geo-marketing, regulatory affairs, government affairs and legal to creative, web, digital operations, PR, tradeshow, and social - to create a strategic approach designed to accomplish objectives and produce effective promotional and communications materials.
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Minimum Qualifications for this position as defined in the Minimum Qualifications for Faculty and Administrators in California Community Colleges published by the Academic Affairs Division, Chancellor's Office, California Community Colleges: Any bachelor's degree and two years of professional experience, or any associate degree and six years of professional experience.
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This role leads the team responsible for evaluation of new deals impacting the Global Regulatory Affairs and Drug Safety (GRADS) organization including, but not limited to Regulatory Affairs, Labeling, REMS, Regulatory Operations, CMC, Medical Safety including PV Operations EUQPPV Office as well as alliance management for existing and new partnerships within the GRADS space.
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Bring innovation and energy as a core member of the Medical Affairs leadership and support VP of Medical Affairs, Oncology in identifying key deliverables, insights, and metrics that demonstrate the value of the Field Medical Oncology organization; track and communicate quantitative and qualitative data from Field Medical activities that demonstrate customer impact with senior leaders across GH on a regular basis.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. This individual will be the key interface between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance.
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The Medical Science Liaison will also work cross-functionally with internal and field-based roles of the Commercial team and other Clinical Affairs team members to guide product strategy, medical education, and customer interactions, aiming to implement our products into clinical routine.
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affairs job Title: regulatory affairs Company: Thermo Fisher Scientific in Palo Alto, CA
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