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The Senior Manager, US Medical Review will sustain and promote Alexion’s professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech industry by providing high quality Medical Review of all material used by the Commercial and Medical teams.
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DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.
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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). Review and approve legal, operational, environmental, engineering and appraisal reports created as part of the due diligence process.
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Support data review of cell therapies, AAV products, and Critical Components. Experience in data review, organization, and analysis using statistical software. Review CDMO stability protocols and author/review internal stability protocols.
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In addition, the Associate Director will provide essential medical and scientific expertise, review, advisement and oversight to support development of high quality promotional and medical materials, internal training materials, and communications as part of the Promotional Review Committee (PRC) and Medical Review Committee (MRC.
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Develop and execute efficient strategies for target identification, prioritization and validation; review, propose, initiate, and implement new pre-clinical therapeutic antibody drug discovery and development programs in the field of Immunology and Inflammation.
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Collaborate with CRO and academic partners; employ cutting-edge in vitro and in vivo animal and human models to advance drug discovery and development programs up to and including IND filing. Extensive experience in flow cytometry, as well as molecular and cellular biology.
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Join Takeda as a Scientific Director, Pathology in Cambridge, MA, where you will be responsible for active cross-functional collaboration, interdisciplinary project team participation, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data, preparation and review of regulatory documentation, study reports and manuscripts.
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The Pre-op Review Nurse evaluates preoperative optimization of scheduled surgical patients via telephone screening calls and by reviewing pertinent clinical documentation. The Pre-op Review Nurse needs to have strong critical-thinking skills, a comprehensive nursing background, and good interpersonal and communication skills.
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The dispatcher for Public Safety operates, including planned synchronization, all video surveillance, audio messaging and response throughout the division with acute focus on current deployment and emergency response, and information intake for review and analysis by supervisory management.
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Author and review regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) for technical accuracy, regulatory adequacy and respond to health authorities concerning toxicology issues. Provide scientific direction and pathology expertise to project specific IHC, ISH and spatial endpoints in collaboration with the DSRE Investigative Pathology and Toxicology labs, DMPK, and Drug Discovery Unit translational pathology groups.
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Where permitted by federal or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances: Amphetamines, THC (marijuana), cocaine, opiates, phencyclidine.
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Provides legal support and guidance to the government affairs and funding teams, including government contracting, grant application and overbuild challenge review and drafting for the Broadband Equity, Access and Deployment (BEAD) Program and other local state and county funding programs.
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Assist the investment team with coordination of operational due diligence and legal review for prospective investments. The Analyst will report to the Chief Investment Officer but will work under the close supervision of other senior investment team members as an integral part of the small generalist investment team, assisting with all functions (investment and operations) pertaining to the management of the portfolio.
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The Conflicts Attorney directs and conducts specific processes in the Conflicts department, including timely and thorough review, identification and resolution of conflicts of interest, preparation of conflicts waivers, recommendations regarding ethical wall implementation, and other ethics related responsibilities.
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