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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer). Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer.
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Internally interact extensively with colleagues from various departments and affiliates, including Medical Affairs, Corporate Sustainability & Social Impact (CSSI), Alliance Development, Sales & Marketing, Procurement, IT, Compliance and Legal.
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Applicants must possess a current and valid license as a Speech Pathologist/Audiologist issued by the Audiology and Speech-Language Pathology Advisory Committee, Division of Consumer Affairs, Department of Law and Public Safety.
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Demonstrated experience in post-marketing medical affairs GxP activities (e.g., research, medical education) and related regulations, standards, and business requirements. Eclaro is looking for a Medical Policy Advisor (Medical Research) for our client in Lawrence Township, NJ.
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Work in cross functional teams (e.g. Product Development, Marketing, IT, Procurement, External Affairs, Regulatory) to develop and maintain environmental sustainability and safety initiatives by providing expert advice, modeling, calculations, and documentation.
$102,000 - $183,000 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Provide support in production or validation of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission. This position will be responsible for leading the programming aspect of a project for all programming deliverables from the single study through to regulatory approval.
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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). We have an exciting opportunity for a remote, licensed High Net Worth Service Associate in the Greater New Jersey Metro area.
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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Manufacturing Science & Technology Specialist SRG offers flexible staffing solutions with a national presence.
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Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly desired. Minimum of 10 years drug development/FDA/regulatory related industry experience required.
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Offer user support and feedback on references and core claims library within the Medical/Legal/Regulatory review and approval system (Veeva Vault PromoMats) Maintain reference and claims library relevancy, working with Medical/Regulatory, conduct periodic audits of the information on file.
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Knowledge and experience in risk control and/or occupational health and safety training programs at the management, supervisory, employee and regulatory compliance level. We’re a recognized Elite Agency award winner and a leading property and casualty broker, benefits consultant, wealth manager, and retirement plan advisor.
$85,000 - $115,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products.
$158,496 - $173,326 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Maintains knowledge of industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/technologies, government/private grants and contacts, new drug development and approvals, related patent grants and notifications, market growth of small, med, and large cap companies.
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Possess CISSP certification (or similar) and knowledge of national and international regulatory compliances and frameworks such as ISO, SOX, BASEL II, EU DPD, HIPAA, and PCI DSS. This position reports to the Sr. Manager of Security GRC. The scope of this position is global and enterprise wide and considers the information security implications unique to all Edwards divisions when developing governance and risk management strategies.
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regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in Lawrence, NJ
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