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Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.
Full-timeExpandUpdated 20 days ago - UpvoteDownvoteShare Job
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Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
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Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs and deep experience in oncology; precision medicine given preference.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Director, Global Regulatory Affairs, Precision Medicine & Digital Health Site Name: USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - London - New Oxford Street, USA - Massachusetts - Waltham, USA - North Carolina - Durham.
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DescriptionPOSITION SUMMARY:The Program Manager of Faculty Affairs works closely with senior department leadership, including the Ophthalmology Department Chair, Vice Chair for Ophthalmology Promotions and Reappointments, the Director, Ophthalmology Administration and the Harvard Medical School Office of Faculty Affairs.
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Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and Payers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities.
Full-timeExpandUpdated 19 days ago - UpvoteDownvoteShare Job
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The Medical Affairs Liaison (MSL)/Sr. Medical Affairs Liaison (Sr. MSL) will be accountable for engaging health care providers in high-quality scientific exchange regarding the science and clinical application for specified products within our portfolio.
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Role Summary The Chief Medical Affairs Office’s Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through LOE for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products.
InternExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Must be enrolled in an accredited college or university and pursuing the following degrees/majors: Bachelors and/or Masters in Business (Supply Chain, Logistics, Finance, Tax, or other business-related major), International Affairs (International Studies, Political Science, Sociology), Data or related degree, or equivalent program.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Leads engagement with internal key stakeholders (e.g. Global Medical Affairs, MCE, Region/LOCs, MPD, Global Outcomes Research and Epidemiology [GEO], and Publications) as needed. The Associate Director, Global Scientific Communications, Mature Brands, is a dynamic, strategic role within Global Medical Affairs that collaborates with cross-functional partners to own one or more disease areas / assets on a Global level.
$234,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Office of External Affairs at Northeastern University is looking for a talented, hard-working, and highly motivated candidate to serve as the Executive Assistant to the Senior Vice President (SVP.
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10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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What a Senior Medical Science Liaison contributes to Cardinal Health:The Senior Medical Science Liaison acts as a representative of the NPHS medical affairs department to support Cardinal Health customers, the scientific development of drug products, and medical education.
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Work with Community and Legislative Affairs to conduct community engagement with external stakeholders on fare policy decisions. Minimum Qualifications:Bachelor's degree from an accredited institution in public policy, public administration, political science, urban planning, urban studies, or related field.
Full-timeExpandApply NowActive JobUpdated 19 days ago
affairs job in Waltham, MA
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