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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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This role will be as part of a global team supporting ESG and Government Affairs required and voluntary disclosures as well as supporting the office of the CSO as needed with sustainability data analytics and management and researching new and upcoming sustainability related grant opportunities and regulations.
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Oversees regulatory compliance in partnership with the Chief Regulatory Affairs Officer, across all Temple campus', including but not limited to Temple University Hospital, Northeastern Campus, Episcopal Campus, Jeanes Campus and Temple outpatient clinics.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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Cal Maritime offers seven baccalaureate degrees in Business Administration, Global Studies and Maritime Affairs, Facilities Engineering Technology, Marine Engineering Technology, Mechanical Engineering, Marine Transportation, and Oceanography.
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The Deputy Director of External Affairs will provide be responsible for communications and recruitment, and scheduling of surge staffing. This role will also support interdepartmental and external affairs on behalf of the Managing Director's Office, with a focus on Election operations and administration.
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Reporting to the Associate Director of Regulatory Affairs, the Veeva Quality Assurance Lead will serve as a lead for the Veeva Quality Assurance Specialists in day to day operations, will review, itemize and migrate all regulatory documentation from the current document management system to the SiteVault platform.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Design / develop project plans as well as the associated technical reports, cost estimates, and specifications for water/wastewater treatment & conveyance projects; this will include coordination with regulatory agencies for associated permitting.
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The incumbent is responsible for analyzing PGW regulatory compliance in communications and actions from regulators and ensuring operating practices are in accordance with local, Commonwealth and federal regulations and requirements.
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Demonstrated experience with the legal, regulatory and technical issues related to the ad tech industry and emerging technologies or privacy issues including iOT, AI and biometrics. Strong familiarity with the relevant legal and regulatory landscape in this area is required, as well as experience in providing counsel on U.S. and international data privacy and information security laws.
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Maintain or acquire HIV Specialist (AAHIVS) certification through the American Academy of HIV Medicine§ Comply with all governing standards and policies promulgated by PHMC, DOH, Joint Commission and other accreditation/regulatory bodies as well as Infection Control and Environment of Care Guidelines and Procedures.
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The EHS Specialist I will also be responsible for support and enforcement of regulatory requirements for healthcare from the Joint Commission, the PA Department of Health, OSHA and local codes and ordinances.
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Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
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This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be. Adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.
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regulatory affairs jobs Title: sr Company: Abbott Laboratories in Philadelphia, PA
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