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The Director, International Strategic Initiatives will support international patient growth initiatives, improve relationships with referring providers and offices, expand brand recognition, improve access for high priority/high urgency patients, and increase awareness of Dana-Farber Cancer Institute clinical service and clinical research expertise within the international referrer community and among foreign government embassies and health ministries.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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This role requires a significant degree of collaboration as well as influencing and driving strategic alignment across multiple functions (Brand Marketing, Medical Affairs, Public Affairs, HEOR, Payer Account Management, and Field Reimbursement) to ensure goal alignment and to meet corporate objectives.
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This is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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Reporting to the Chief of Communications and Public Affairs, the Senior Director of Events will oversee the strategic planning and timely execution of events that reflect our new, community-centric strategic direction and contribute to our vision of advancing a region where access to financial well being is universal and prosperity is shared across race and ethnicity, and provide and special experiences for target audiences and affiliated marketing components.
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Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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Comprised of teams dedicated to internal/external communications, public affairs, and policy, our environment is fast-paced, ultra-collaborative, and ever-changing. Working with our communications partners in Fidelity’s Corporate Affairs, our mission is to provide the best customer service to our business partners while supporting the goals of Fidelity by utilizing authentic storytelling and creating experiences to connect with, inform, and inspire all of our 74,000+ associates and our customers, all while driving the business forward.
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This 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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The Executive Office of Energy and Environmental Affairs, Office of the General Counsel seeks applicants for Associate General Counsel & Procurement Director. The Executive Office of Energy and Environmental Affairs (“EEA”) serves Commonwealth residents interested in outdoor recreational activities, clean energy solutions, and those who work with animals and livestock.
$75,653.45 - $90,100 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Boston Public Schools seeks an exceptional Foreign Language Teacher who is highly qualified and knowledgeable to join our community of teachers, learners, and leaders. Reports To: Principal/Head of Schools Responsibilities Teach: Foreign Language Core Competencies: Using the Rubric of Effective Teaching, the Office of Human Capital has identified priority skills and abilities that all BPS teachers should possess: Accountability for Student Achievement (II-1.
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Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. Similar Jobs (5) Director, Regulatory CMC, Cell & Gene Therapy (Boston) locations Boston, MA time type Full time posted on Posted 4 Days Ago External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy locations Boston, MA time type Full time posted on Posted 30+ Days Ago Supply Chain Manager - Cell & Gene Therapy (Hybrid) locations Boston, MA time type Full time posted on Posted 25 Days Ago.
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The Medical Science Liaison (MSL) team is responsible for establishing, fostering, cultivating and maintaining relationships with HCPs with the end goal of educating and providing information on the company products, developing and building relationships with both national and regional medical thought leaders, facilitating research endeavors, and educating HCPs. In addition, the MSL provides scientific insights back to Medical Affairs management.
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Board certified or board eligible by the American Board of Psychiatry and Neurology in General Adult Psychiatry, or by a comparable foreign national certifying organization. Doctor of Medicine (M.D.) degree or foreign equivalent medical degree and completion of a four year general psychiatry residency.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. Design toxicity studies: coordinate with Preclinical Outsourcing for placement and monitoring of the studies as well as the Bioanalytical and DMPK groups regarding integration of bioanalysis and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports.
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foreign affairs jobs Title: data scientist Company: Citi in Medford, MA
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