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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 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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Identify and advance the Medical Affairs Operations programs to ensure implementation of best practices including adherence to ACCME, PhRMA, and IMC code. Assists with payment processing for Medical Affairs related activities such as educational grants, publication grants, investigator-initiated studies, and other related activities.
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Senior-level global leadership role that is accountable for the oversight and management of strategic planning and execution of all external, leadership & employee communications, issues & crisis management and other functional communications supporting the global CSL Behring Access, Business Effectiveness, Commercial Development & Medical Affairs organizations.
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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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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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The Environmental, Health & Safety Specialist is primarily responsible for providing expertise and support, reporting to the site Plant Manager with a dotted line to the EHS Director as well as advising other key members of the SH&E community of applicable safety, regulatory and legal requirements for the supported site(s.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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A Brief OverviewResponsible for obtaining prior authorization, facilitating patient access to medication, coordinating patient care to include documentation, dispensing and distribution under the supervision of licensed pharmacist meeting regulatory and accrediting agency requirements.
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Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, New Product Introduction and technology transfer processes. Guidance and cross project support to Regulatory, Quality, and Global Supply Chain.
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Advise the Nursing Home Administrator, Director of Nursing and Food Service Director as needed on all clinical aspects of nutrition care and abides by all standards set forth by applicable regulatory agencies and licensing boards.
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Oversight and preparation of compliance plans, reports, and permit applications for multiple state and federal environmental regulatory programs associated with the Clean Air Act, Clean Water Act, RCRA, EPCRA, and the Oil Pollution Prevention Act.· Conduct site visits to gather data and information and collect samples (soil, water, air) to support environmental compliance at industrial, commercial, and institutional sites.
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Job DescriptionEurofins Lancaster Laboratories PSS is searching for a Quality Assurance Laboratory Specialist in West Point, PA.The Quality Assurance Laboratory Specialist ensures that all necessary laboratory documentation (CRs / ACRs, IOQs, PQs, etc) is reviewed, approved, valid and compliant with all site procedures, following Policies and Guidelines and Regulatory requirements.
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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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Working knowledge of various regulatory security requirements – particularly Sarbanes-Oxley (SOX), HIPAA, and HITECH.Working knowledge of common cyber security frameworks such as HITRUST, NIST, CSC, or others.
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regulatory affairs jobs Title: affairs specialist Company: Beigene in Collegeville, PA
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