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Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometri
The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharma
Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Report
Lead to deliver high quality and timely regulatory submissions in alignment with corporate goals, and in compliance with all applicable regulatory requirements. Excellent writing and editorial skills, ability to collaborate on development of high‑quality clinical‑regulatory documents, eg, invest
ORIC Pharmaceuticals is seeking a Director/Associate Director in Regulatory Affairs to support clinical development of oncology products. The successful candidate will support regulatory submissions, collaborate across functions, and ensure compliance with regulatory requirements. This role requires
This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the pr
Experience selling remote patient monitoring (RPM), digital health solutions, medical devices, prosthetics, wound care, diabetes care, or related healthcare technologies. The National Sales Manager will serve as a key commercial leader, supporting regional sales representatives and strategic partner
Maintain ongoing awareness of program‑ and trial‑level quality, safety, and efficacy issues, and provide quality oversight and consultation to ensure GCP compliance and continuous inspection readiness throughout the trial. This individual actively leverages audit / inspection outcomes / trends t
The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. Coordinate governance proc
Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. The ideal candidate will have over 10 years of experience in the Medical Device industry and at least 5 years in Regulatory Affairs. This role involves deve
Associate Director, Regulatory Affairs CMC page is loaded## Associate Director, Regulatory Affairs CMCremote type:. Works closely with the Senior Director, Regulatory Affairs CMC to lead and prepare regulatory submissions (authoring, timeline planning, etc. Position Summary:**The Associate Director,
A leading pharmaceutical company is seeking a Senior Medical Affairs Operations Manager to oversee the execution of clinical studies and manage the medical affairs operation. The role requires managing clinical protocols, leading teams, and ensuring compliance with regulatory standards.
Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz
Compliance & Quality Assurance Engineer. Develop, review and accept Quality Assurance Plans (SQAP/HPAP) to ensure certification compliance. Understand, update, and maintain QMS systems in compliance with ISO9001, AS91000, and other equivalent industry standards in addition to ensuring compliance to
A pharmaceutical company in San Diego seeks a Manager of Medical Writing Operations for Trial Disclosure. This role is integral to clinical trial transparency, responsible for ensuring compliance with disclosure regulations.
The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharma