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Developing knowledge of the Specialty franchise & the Medical Affairs/HEOR organization and proactively guiding commercial, medical and regulatory clients. Working cross functionally with Commercial, Medical Affairs, Regulatory Affairs, the Office of Ethics and Compliance, Public Affairs, and other departments to find solutions to meet business objectives consistent with the law, applicable policies/procedures, and AbbVie's Code of Conduct.
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O Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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As the Director, Regulatory Affairs CMC you will be responsible for developing and implementing regulatory strategies for US CMC activities throughout the product lifecycle. Direct experience with all types of CMC regulatory documents and sections (INDs, NDA, BLA, supplements, and responses) in eCTD format.
$174,000 - $254,150 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience with complaint handling, quality & regulatory processes preferred. Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) and clinical trial databases (e.g., Medidata Rave, Argus.
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Candidates for Director, Strategy should be passionate about providing quality opinion research to drive client decision making in public policy, social marketing, candidate and ballot issue campaigns, non-profit advocacy, corporate public affairs, and government.
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Abiomed, part of Johnson & Johnson's MedTech is recruiting for a Clinical Safety Specialist , located in Danvers, MA or Remote. o Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or overseeing third party management of committee activities per study SMP and associated Charters.
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The Associate Director, Immunology Medical Affairs Data Analytics will collaborate with colleagues across the Immunology US Medical Affairs organization, such as Medical Heads, MSL Field Directors, Integrated Evidence Team Leads, as well as data analysts in the business units with whom Medical Affairs collaborates: Commercial (Franchise and Brand), Global Medical Affairs, Janssen Scientific Affairs, and Strategy Analytics and Transformation.
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In conjunction with the Law Registrar and Associate Dean for Academic Affairs, prepare and update the class schedule. Prepare paperwork and coordinate UH course creation process with the Office of Graduate Education and Office of Vice Chancellor of Academic Affairs.
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Provide referrals to other internal and external services, including Senior Associate Dean for Student Affairs, Disability Access Office, mental health counseling within KPSOM or KP, career advising, and medical consultation as appropriate.
$109,600 - $141,790 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Administrative units include the Offices of the Dean, Vice Dean, Associate Dean for Student Affairs, Associate Dean for Research, Associate Dean for Clinical Affairs, Associate Dean for Extramural Clinical Practices, Assistant Dean for Dental Education and Informatics, Assistant Dean for Educational Support and Faculty Development, Assistant Dean for Academic Success and the Assistant Dean for Business Operations and Financial Affairs.
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JOB TITLE: Algebra Instructor REPORT TO: Director of Academic Affairs DEPARTMENT: Academic Affairs POSITION TYPE: Seasonal part-time — Summer FLSA: Exempt SUMMARY: Oliver Scholars seeks a math instructor to plan and implement an Algebra 1 curriculum for eighth grade students.
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Description :PRIMARY PURPOSE/GENERAL DESCRIPTION: Reporting directly to the Vice President for Student Affairs and Dean of Students (VPSA/DOS), the Assistant provides administrative support for the VPSA/DOS in a one-on-one working relationship.
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Support authoring and manage document workflows for planned major submissions including health authority meeting packages, original INDs/CTAs, and protocol amendments:· Lead interactions with external regulatory submissions vendor· Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.
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Partner collaboratively with the Regulatory Affairs, Computational Biology, and Quality Assurance Teams across the enterprise to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards.
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TA specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, and commercial, to manage global response topics and content.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Thermo Fisher Scientific
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