- J&J Family of Companies (Santa Clara, CA)
- …of scientific content (for internal information purposes as well as for regulatory submissions ), including conference reports, data summaries, disease state ... protocols, case report forms, instructions for use, clinical study reports, and regulatory submissions . + As needed, assist in the Medical Affairs review of… more
- Stryker (San Jose, CA)
- …and medical writing skills. + Knowledge of clinical operations, risk management, regulatory submissions and US and international guidelines. + Ability to ... this role, you will collaborate closely with cross-functional teams, including Regulatory , Clinical, Quality, and Marketing to ensure the successful preparation of… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed ... contact for long term follow-up patients only. + Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse… more
- J&J Family of Companies (Irvine, CA)
- …statistical reports that may be incorporated into internal clinical reports or regulatory submissions . + Contribute to peer-reviewed articles independently, in ... independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing… more
- Medtronic (Northridge, CA)
- …concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions . The Senior Product Engineer applies scientific ... and projects + Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to biocompatibility and/or clinical evidences +… more
- Abbott (Alameda, CA)
- …Participate in the interim and final reviews of study data in preparation of regulatory submissions . + Involved in the preparation of all applicable documents ... (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Deviations, CAPAs, Biological Product Deviation and Complaints. + Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with ... a highly regulated manufacturing environment. + Direct experience with regulatory health authority submissions (eg IND, NDA,...+ Direct experience with regulatory health authority submissions (eg IND, NDA, BLA, MAA) and/or inspections. +… more
- Sumitomo Pharma (Sacramento, CA)
- …medical writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and ... Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions , ensuring compliance with regulatory expectations. + Collaborate closely… more
- Ascendis Pharma (Palo Alto, CA)
- …Contribute to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions + Maintain up-to-date knowledge of relevant ... At least 4 years of pharmaceutical industry experience + Experience with regulatory submissions and interactions Estimated compensation 170-190K/year USD DOE… more
- J&J Family of Companies (Irvine, CA)
- …new products + Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals. + Approve Design ... with key customers and stakeholders (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand… more