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Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.
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Clinical Affairs Consultant - 8 month contract + possible extensions/conversion. The Clinical Affairs Consultant reports to the Director of Clinical Affairs in the business.
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The CCMO partners with Harvard Public Affairs and Communications and the HDS associate dean for development and external relations regarding media events, external relations, and campaign communications strategy and implementation.
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This position will report to the Senior Vice President, General Counsel Commercial and and will require you to work in a matrix setting in a fast paced, rapidly growing organization, partnering effectively with various stakeholders, including with colleagues in across the Commercial Legal team as well as Medical Affairs, Commercial, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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Works cooperatively with institutional colleagues, including but not limited to: Concert Operations, Professional Writing & Technology Division, Music Education, Music Therapy, Institutional Advancement, Academic Affairs, Music Production and Engineering.
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Collaborate with other offices (including but not limited to) the Advancement Office, Finance Office, Information Technology, Bursar, Admissions, Registrar, and Student Affairs to ensure mutual support of each other’s functions and continued effectives of the University’s operations.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Proven track record in API and solid formulation process development, including scale-up and technology transfer, with a robust understanding of HME and SDD chemistry.
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5% - Special Projects: Contributes to and leads special projects in Graduate Affairs identified by the Assistant Provost for Graduate and Postdoctoral Professional Development or the Associate Provost for Graduate Affairs, including developing new resources or initiatives, or conducting high level data collection or reporting for University leaders.
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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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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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This position is responsible for assisting the Vice President, Corporate Secretary and Chief of Staff for all activities related to the Bank’s Board of Directors and providing executive level assistance to senior leadership and serves as the Administrative Officer of the Corporate Affairs Department.
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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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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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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
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affairs job Title: principal consultant in Milton, MA
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