- Envista Holdings Corporation (Brea, CA)
- …Manage the submission process for marketing materials requiring review and approval from Regulatory Affairs and Legal Affairs , ensuring all assets comply ... and regional marketing teams, creative agencies, and internal departments (including Regulatory and Legal) to ensure seamless communication and efficient project… more
- BeOne Medicines (Emeryville, CA)
- …developmental and approved BeiGene products + Actively leads Development and Medical Affairs product teams in the identification of, and handling of product safety ... executes Crisis Management response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature of response, best course of… more
- AbbVie (Irvine, CA)
- …management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs . The Associate ... development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, or GMA) to create development… more
- AbbVie (South San Francisco, CA)
- …life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The ... development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, and GMA, etc.) to create… more
- Genentech (South San Francisco, CA)
- …Science Strategy team, to translate insights into actionable recommendations that strengthen clinical trial design, medical plans, and regulatory strategy. The ... understanding of population science and the scientific and ethical considerations in clinical research; Familiarity with global regulatory frameworks and global… more
- Sanofi Group (San Diego, CA)
- …robust, impactful plans for the key accounts that reflect the Medical Affairs strategic imperatives and anticipate pre- and peri-launch needs. + Collaborate closely ... matrix meetings. + Continuous engagement in key accounts to create clinical value and demonstrated impact through exceptional/innovative field medical results and… more
- Genentech (South San Francisco, CA)
- …The Sr. Medical Science Director/ Sr. Medical Director will provide exceptional clinical and scientific leadership for medical affairs activities, aiming to ... plans + Provide a medically sound and clinically meaningful perspective for regulatory and other scientific communications + Contribute to strategic medical plans,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** Otsuka is looking for a strong Clinical Statistician in the Medical and Real World Data Analytics organization to provide statistical expertise for ... analysis of clinical trials data beyond the study endpoints, including secondary,...scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end… more
- Edwards Lifesciences (San Diego, CA)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... creation of machine learning and AI foundations for the assigned Business Unit Clinical Affairs + Offering technical guidance on predictive modeling and… more
- Ascendis Pharma (Palo Alto, CA)
- …compliance audits. . Functions as a patient safety advisor to Ascendis Clinical Development Organizations, Medical Affairs , Commercial Organizations and PV ... all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.… more