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Other / Regulatory: Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes and engages in practice operation changes.
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Detailed understanding of regulatory and professional guidelines associated with the compliant dissemination of medical information and HCP engagement (OIG, FDA, AMA, ACCME, and PhRMA guidelines.
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Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker-based approaches. Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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The IRT Lead will also partner with IGOT management for quality investigations, CAPA commitments and continuous improvements, SOP review and revision activities, support regulatory inspections, and limited duration teams where appropriate.
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You will be responsible for developing, and being the technical lead for new Enterprise Content Management & Composition applications based on: business requirements, regulatory requirements, architect solutions, and existing technologies.
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Reporting to the Head of Process and Analytical Development – Cell Therapy, the Director of Analytical Development will be accountable for the flawless execution of the Cell Therapy Analytical Development activities (internal and client-focused); spanning technical development, method transfer, manufacturing, product release and successful preparation of regulatory submissions.
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Partner with legal, medical, regulatory, HCC, and CPC partners to obtain approval of marketing and contracting materials. The Group Product Director for Immunology Channel Marketing is accountable for the leadership and development of channel specific strategies within Health Systems, Supergroups, Infusion Service Providers and In-Office Infusion Suites for the Immunology Portfolio, inclusive of the Gastroenterology, Rheumatology and Dermatology franchises.
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Perform FAI/CVI (Annual) inspections on all fleet vehicles including tractors, trailers, converter dollies, light-duty vehicles, and any other company-owned equipment in accordance with all federal, state and local legal and regulatory agencies.
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Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.
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Colleague fundamentally performs the ePALMS system "Market Coordinator (MC) role in close collaboration with the Global Regulatory Affairs (GRA) Strategy functions at Pharmaceutical Country Offices (PCOs) and is the central regulatory point of contact for the PGS plants/Artwork Centers (AWC.
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Must have national accredited wound certification (CWS, CWCN, WCC, CWON, WOC, AWCC)or be committed to complete Advanced Wound Training and national accredited Wound Certification within 1 year of hire (For those hired with wound certification, completion of a fast-track hybrid program for regulatory wound care requirements will be provided.
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Basic Minimum Qualifications:Degree in Biology, Cell Biology or Virology is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineeringExperience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
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Strong knowledge of HACCP, SSOP, SOP, USDA, and FDA standards. This role is crucial for ensuring that our operations meet all company, customer, and regulatory standards. Collaborate with Plant Manager and Sanitation Manager to maintain high standards of facility cleanliness and safety.
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Collaborates with the Clinical Manager and Education Coordinator in driving FMS quality standards through education regarding all ESRD regulatory and legal requirements and the practice of Continuous Quality Improvement.
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Follow OSHA regulations and other regulatory agencies relating to job site safety, demonstrates safe work practices. Installation of different types of roofing systems such as BUR, EPDM, Single-ply, coatings, and other forms of low-slope roofing systems.
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usda regulatory jobs in Lansdale, PA
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