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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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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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These offices include the Admissions, Financial Aid, Academic Affairs, Advanced Graduate Education, International Affairs and the Health Science Bursar's Office. Direct registrar, academic affairs, or student affairs experience in graduate or professional school setting is preferred and will be considered in lieu of experience in other student services areas.
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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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.
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The successful candidate will have a strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and commercial (NDA/MAA) submissions. This role is accountable for the planning and technical execution of the CMC regulatory strategy and for representing Regulatory Affairs-CMC in cross-functional teams and with external partners.
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They collaborate with faculty, the HMS Dean for Clinical and Academic Affairs, and others in the HMS Dean’s Office to achieve these objectives in supporting gender equity and positive faculty experience through development and implementation of programming that includes a focus on community building, mentoring and leadership training, and promoting the visibility and interests of women in science.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments.
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Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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Clinical Pharmacist Manager functions as both a clinician and manager dedicated to providing support of medication use systems and delivery of optimal medication therapy throughout Newton-Wellesley Hospital.
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Our research aims to improve quality of life, well-being, symptom and pain management, and reduce caregiver burden:For example, a Clinical Research Coordinator to support a large multi-site clinical trial study that focuses on the comparison of care delivery models to support older adults with complex healthcare needs.
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The Assistant SRNA Program Director collaborates with Chief CRNA and Clinical Director to maintain the goal of overseeing student education. Directly communicates with Chief CRNA and School of Nurse Anesthesia to develop action plans to support SRNA if clinical deficits are noted.
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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
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clinical affairs jobs Company: Biophase in Watertown, MA
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