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The Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives within the US Medical Affairs organization and will partner with TA Leadership teams and cross functionally to execute on projects in line with the functions overall strategic goals.
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Provides administrative support for the Associate Dean for Academic Affairs & Director of Clinical Affiliations. Provide support to Associate Dean for Academic Affairs and Director of Clinical Affiliations, as directed.
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Work closely with the Data Governance Lead to develop and maintain a right size data catalog of and data lineage for commercial and medical affairs applications. For the expansion of our Business Information Systems (BIS) team, argenx is looking for a Data Architecture Lead with focus on the Commercial and Medical Affairs functions.
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Collaborate with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.
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Work closely with CMC Manufacturing, Quality Assurance, Regulatory Affairs, Procurement, and Commercial Operations to integrate logistics activities and ensure compliance with international regulations, including Good Distribution Practices and customs.
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Job DetailsDescription GENERAL SUMMARY As a member of the Academic Affairs team, the Director of Student Disability and Accessibility Services provides leadership for the design, development, and implementation of accessibility and disability services and programs for Regis College students.
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Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) Expertise with Medidata Rave EDC system. Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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Subject matter expertise in matters pertaining to behavioral threat assessment, both international and domestic (U.S.) affairs, and violent extremism as they pertain to the current threat environment.
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The Clinical Affairs Specialist, MCS augments the sales process for the Teleflex Intra-Aortic Balloon Pump (IABP) by partnering with sales representatives and the current or intended customer to drive the clinical aspects of product evaluations, installations, and post-installation training needs to advance and/or maintain stages within the product adoption cycle.
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The Co-ops & Careers Department, within the Academic Affairs Division, is seeking applicants for a Co-op & Career Adviso r with strengths in career advising/coaching, teaching, recruiting, interpersonal communication, and collaboration.
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Through a comprehensive understanding of the diagnostic and care landscape, the candidate will closely collaborate with the International Business Unit (IBU) marketing and medical teams, Government Affairs, and International Communication teams to execute, in partnership with the local affiliate teams, integrated solutions designed to remove obstacles to optimal patient pathways.
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PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering. 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations.
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THE OPPORTUNITYThe Lead, Clinical Data Management provides project oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming.
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Serving as a field resource for The Medical Affairs Company (TMAC), the Clinical Trial Liaison (CTL), reporting as Early Clinical Liaison , will represent the Company’s Respiratory Clinical Development program.
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Relationships Reports to the Senior Director, Clinical Pharmacology for the U.S. East Coast Hub. Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory, Data Science (statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally with leadership in Medical and Science.
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affairs job in Newtonville, MA
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