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Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities.
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Deepen understanding of more complex accounting, profitability, regulatory, and business segment nuances, including cost allocation methodology, funds transfer pricing, and vendor contracts. Subject matter expert on regulatory reporting requirements, business cycles, origination channels and accounting flow for assigned area of responsibility.
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Collaboration and Communication: Work closely with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Data Management, to ensure successful validation activities.
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This role reports to the Director of Regulatory & Medical Affairs. The Senior Medical Science Liaison acts as a representative of the Nuclear & Precision Health Solutions (NPHS) medical affairs department to support Cardinal Health customers, the scientific development of drug products, and medical education.
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Knowledge of the Legal and Regulatory landscape pertaining to pharmaceutical marketing. The Head, Marketing position will serve as a key member of the U.S. Commercial AIR leadership team, leading the development and execution of HCP and patient-focused strategic marketing programs for the Chiesi USA in-line portfolio in the Respiratory setting with primary focus on Asthma/COPD.
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OverviewRegulatory Technology aims to be an industry leading function that delivers sustainable regulatory compliance through technology automation and competitive operating leverage to create a safe and controlled operating environment that protects the Deutsche Bank franchise and its clients.
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Within Wolters Kluwer ESG division, we offer comprehensive tools and expert guidance to companies to help meet regulatory requirements to support sustainability efforts and manage ESG risks efficiently.
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The Senior Medical Science Liaison (MSL) is an integral member of the medical affairs team. The MSL is an integral member of the medical affairs team. Versed in technical and scientific languages to communicate with Key Opinion Leaders (KOLs), Medical Affairs, Research and Development, as well as other key internal and external stakeholders.
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Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolution, and assist with strategic forward planning.
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Deciphera is seeking a Medical Science Liaison (MSL), field-based scientific/clinical experts that will report to the Senior Director, Medical Affairs within the Medical Affairs (MA) department.
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Support product stewardship, regulatory and sustainability teams including product development, business initiatives and market assessments ensuring regulatory compliance in conjunction with corporate sustainability goals.
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The Global Export Compliance Manager will reduce business risk through collaboratively developing, implementing, managing and monitoring Wabtec's export compliance program as Wabtec's export regulatory subject matter expert with a focus on US regulations.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP.
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Experience in a Business Analyst capacity would be bene cial, speci cally within Research and Development IT, Regulatory A airs /Technical Operations in Biotech, Oncology, or Clinical applications (Pharmaceutical / Life Sciences environment preferred but would consider candidates from another regulated industry.
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regulatory affairs jobs Title: affairs Company: Jobget in Cary, NC
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