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This client is a growing international full-service CDMO/CRO within the biotechnology space looking to aggressively expand its footprint in the US. The company has a strong base of API/Small Molecule, Biologics, Clinical Research, Bioanalytical Sciences, DMPK, Cell and Gene Therapy and other capability centers across the US. This business has developed a fantastic brand in the US through exceptional service which drives repeat business.
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The ideal candidate will have deep expertise in FDA regulation of drugs, biologics, cellular and gene therapy products. Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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The TCT Division is focused on the development and implementation of novel cell-based and immune therapies (including CAR-T, vaccine, and gene therapy) as well as autologous and allogeneic hematopoietic stem-cell transplantation.
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Goals include, providing an intellectual environment for a diverse community of research scientists dedicated to basic and translational research; these scientists explore the molecular biology of viral and non-viral vector delivery systems for use in basic research with the eventual goal of human gene therapy.
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Provide technical support to SO&IW liaison to OSD/Legislative Affairs, Congress, and budget meetings. 10 or more years of Joint, OSD, Service experience working with the staffs of the House and Senate Armed Services, Foreign Affairs/Relations, Intelligence, and Appropriations committees.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Represents Clinical Affairs line in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams as applicable.
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Hands-on experience in tissue culture, plate-based assays, RNA isolation, gene expression analysis (qPCR), western blot, ELISA, multiplex protein analysis, flow cytometry preferred. Perform molecular techniques including DNA/RNA isolation, PCR, qRT-PCR, gene expression analysis, cell line engineering and tissue culture as needed.
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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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Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with Clinical Affairs Lead, Clinical Epidemiologist/Medical/Scientific Affairs Lead and Partner representatives.
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Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy.
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Examples of Duties As the chief executive and academic officer of the SIU School of Education, the Dean reports to the Provost and Vice Chancellor for Academic Affairs and works with the faculty and staff in the development and maintenance of the school’s programs and policies.
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consumer affairs gene therapy jobs Title: regulatory affairs in Anoka, Minnesota
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