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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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The Communications Director shall coordinate with senior staff at MassDEP including the Chief of Staff, Deputy Commissioners, Government Affairs, and General Counsel, to plan and direct the Agency’s press strategy, including responding to media inquiries, sending press releases, coordinating social media, and managing press events.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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The Director of Student Affairs reports to the Associate Dean of Student Services and collaborates extensively with each of the programs and their different modalities as well as a multitude of university partners.
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Provide research and analysis on new projects and assignments related to Academic Affairs programs, including fiscal planning as necessary in support of Board of Trustees, Chancellor, Provost and Dean/Director level program reviews, UMass President’s Office, collective bargaining efforts and others as needed.
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We're currently seeking a strong Regulatory Affairs Specialist, (RAS) who will work to ensure that company products and processes comply with all applicable regulations and standards. Bachelor’s or equivalent in Regulatory Affairs or related Science, along with 5+ years' experience in a related industry.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Through proactive outreach and engagement, the Student Success Advisor will ensure each student is aware of and has access to the resources, programs, and supports provided in academic programs, academic support services, accessibility resources, personal counseling, wellness services, student affairs, student aid, international student services, and career services.
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Build effective partnerships with internal stakeholders, including Medical Affairs directors, Clinical Development, Biostatistics, Legal, Discovery, Field Medical, Market Access, and cross-functional members of publications teams.
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Work collaboratively with stakeholders including but not limited to: Government Pricing & Programs, Contract Operations, GTN Forecasting, USMA Data & Analytics COE, Data & Technology Enablement (DTE), Public Affairs, Commercial Legal, Payer Accounts, Trade & Distribution FP&A, Revenue Accounting, Accounts Payable, Internal Audit etc.
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Reporting directly to the Head of Translational Medicine, this individual will oversee the design of translational/biomarker strategies and collaborate closely with cross-functional teams, including Research, Clinical Development, and Regulatory Affairs, as well as external CROs to ensure their seamless implementation into our clinical trials.
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Department/Area Clinical and Academic Affairs Position Description I. OVERALL ROLE AND RESPONSIBILITIESThe HMS Director, Gender Equity for Faculty in Science identifies opportunities, develops programming, and leads efforts to support gender equity in career development, satisfaction, and fulfillment for HMS basic and social sciences faculty.
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About the Role:Join our compassionate Kia Care Consumer Affairs team as a Remote Total Case Specialist. This includes: an industry-leading dispatch management platform powered by Swoop; comprehensive accident management services; knowledgeable consumer affairs and connected vehicle capabilities; and a growing marketplace of services, discounts and support enabled by a robust partner ecosystem.
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affairs job Title: director clinical assoc in Boston, MA
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