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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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Supervise and support reporting units, including Communications, Legislative Affairs, Constituent Services, Hiring and Staffing (Human Resources Liaison office), Federal Policy, Member Engagement, Housing and Homelessness Policy, and MassHealth’s Project Management Office.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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Position SummaryThis 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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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Equity Research Analyst Internship Summer 2025.
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Knowledge of CFTC & NFA swap regulations is preferred to enhance the compliance program and assist the swap dealer to satisfy its regulatory obligations. Assisting in responding to regulatory inquiries, audits, examinations and investigations, and liaising with regulators (CFTC & NFA.
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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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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology, or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist, or clinical laboratory scientist.
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Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. Works collaboratively with the Case Manager, Brewster Ambulance Services Transportation Coordinator and the VPNE care van ambassador to coordinate the various modes of discharge transportation.
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Serving as a field-based extension of Medical Affairs, the Medical Science Liaison (MSL) will represent the Company, a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies that target p53 mutations.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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Sending reminders to clerkship and site directors as necessary and informing the Dean for Educational Affairs, the Dean of Students and the Assistant Dean for Student Enrollment of those not in compliance.
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Open to Medical Lab Technician [2 year MLT degree ] or Medical Lab Scientist / Medical. Hep B, TB, MMR, T-Dap, Flu, Varicella, Covid. Generalist With Blood Bank Experience. Minimum 0-2 years of clinical laboratory testing experience is required.
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7 NorthThe Clinical Leader participates in planning, organizing, implementing and evaluating patient care and developing programs to support clinical care consistent with the mission and goals of Brigham & Women’s Faulkner Hospital as well as the requirements of JCAHO and other applicable federal, state and local regulatory and/or accrediting agencies.
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regulatory affairs jobs Company: Pwc in Boston, CT, Wyoming
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