- J&J Family of Companies (San Diego, CA)
- …area leaders, internal SAS programmers, clinical trial managers, and personnel from regulatory affairs, medical writing, and other disciplines as needed. ... is required. + Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical… more
- Rady Children's Hospital San Diego (San Diego, CA)
- …that are consistent with and recognized by Health Plans nationally recognized medical organizations federal regulatory bodies & contractual obligations of the ... organization. SKILLS REQUIRED: - Excellent critical thinking skills - Strong decision-making ability - Administrative and interpersonal skills - Outstanding customer service skills - Ability to work under pressure MINIMUM QUALIFICATIONS: High School Diploma,… more
- Hologic (San Diego, CA)
- …The ideal candidate plays a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release. The ideal candidate will ... product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR). + Conduct initial...years of experience in post-market quality assurance within the medical device industry such as medical devices,… more
- AbbVie (South San Francisco, CA)
- …team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...+ Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory… more
- BeOne Medicines (Emeryville, CA)
- …+ Preferably 5 or more years of direct experience in Data Disclosure & Transparency, Regulatory Affairs, or Medical Writing. + Experience with Veeva RIM + Core ... and approval of transparency submissions on time and within compliance with regulatory and BeOne requirements + Advanced knowledge of clinical trial transparency… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and federal/state/local statutes and regulations). Staying abreast of industry trends and regulatory changes in the medical education is crucial to inform ... Join Gilead and help create possible, together. **Job Description** The Senior Director, Medical Education & Programs is a global role that requires a visionary… more
- CTG (Woodland, CA)
- …preferred) **Qualifications** * Minimum 3 years' experience in Quality or Regulatory , preferably in medical device, pharmaceutical, or biotechnology industries ... Engineer II will develop and support all Quality Management System (QMS) and Regulatory Affairs (RA) activities in alignment with site quality goals and metrics.… more
- Sumitomo Pharma (Sacramento, CA)
- …programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs ... strategy for Oncology, aligning with SMPA's overall goals and regulatory requirements. + Lead the medical and...goals and regulatory requirements. + Lead the medical and scientific aspects of clinical trials, including protocol… more
- Sharp HealthCare (San Diego, CA)
- …sets.The RN CM I has accountability for maintaining compliance contractual and regulatory compliance with medical groups as applicable and the hospital.The ... position requires the ability to combine clinical/quality considerations with regulatory /financial/utilization review demands to assure patients are receiving care… more
- Abbott (Sylmar, CA)
- …US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more