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Manage the enrollment center welcome area daily operations providing excellent customer service to triage guests including flow of traffic throughout the enrollment funnel (admissions, recruitment & communications, enrollment services, financial aid, bursar/cashier-student accounts, student affairs, and academic affairs, etc.
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In addition, the incumbent will work closely with the Sanofi Vaccines Research and Development, Public Affairs, Regulatory Affairs, Commercial, Value and Access and Franchise and Product Strategy functions globally to support optimal life cycle management for all products.
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management,Commercial and Operations functions.
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Key partnerships include Commercial, Real-World Evidence, Commercial Analytics, Medical Affairs and Market Access as well as outside GCSO with regional Commercial and Medical/Scientific Affairs teams, J&JIM R&D, J&J Technology (JJT) Data Sciences and broader J&JIM teams, and others.
$142,000 - $244,950 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Interact with Regional Market Access/Health Economics / Outcomes Research and Medical Affairs teams to coordinate and develop real world evidence generation in support of their access programs.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
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Global Scientific Communications and Publications has responsibility for the development and delivery of internal and external scientific communication strategy and related tactics including global publications (e.g., abstracts, posters, manuscripts) and scientific materials such as slide decks for use by Medical Affairs around the world.
$116,000 - $161,333 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Support/participate in external regulatory audits (FDA, TUV, Health Canada, Customers, etc.
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Partners with internal stakeholders including CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations are clearly defined and met across participating teams.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication.
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The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.
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For base business hybrid responsibility, key constellation includes local brands teams (including science hub), respective category brand team, respective category claims lead and regional scientific affairs and activation teams.
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
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Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
Full-timeExpandApply NowActive JobUpdated Today
affairs job Title: sr regulatory affairs associate in Bridgewater, NJ
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