- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Clinical Regulatory will report to the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs, Precision Medicine, you ... as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs,… more
- AbbVie (San Francisco, CA)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & ... products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in… more
- Pfizer (South San Francisco, CA)
- **ROLE SUMMARY:** The Senior Manager , Oncology Early Stage Clinical Scientist will work collaboratively with the Global Development Lead (and members of the ... encourages strong partnerships and mutual trust. + Supports the GDL and senior clinical scientist, in developing effective collaborations with project leaders… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Sumitomo Pharma (Sacramento, CA)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Supply Chain** . The Senior ... on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- BeOne Medicines (Emeryville, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:**… more
- Sumitomo Pharma (Sacramento, CA)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... knowledge of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work… more
- Philips (San Diego, CA)
- The Senior Clinical Solutions Manager will play a critical role within Philips Ambulatory Monitoring & Diagnostics (AM&D) Chief Medical Office, responsible ... the business domestically and internationally, including Marketing, Product, R&D, Quality, Regulatory , Operations and Clinical Affairs, to drive coordinated… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Manager , Digital Clinical Operations Solutions Analyst is responsible to implement the GCO digital strategy with the goal ... to increase Global Clinical Operations' productivity and reduce clinical trial...are cohesive, efficient, reliable, and compliant with all applicable regulatory expectations. + Manage the implementation of GCO technology… more
- Edwards Lifesciences (Sacramento, CA)
- …longer and healthier lives. Join us and be part of our inspiring journey. As the ** Senior Clinical Data Manager ,** you will translate clinical study ... your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how… more
- GRAIL (Menlo Park, CA)
- …technology, and healthcare companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and ... management of Otsuka clinical studies, including coordination with other relevant parties (eg, other Otsuka departments, external service providers (ESPs), etc.).… more
- Bristol Myers Squibb (San Diego, CA)
- …and execution of multiple clinical trials (eg significant experience as a senior clinical leader), and exhibits all of the following attributes: + Able ... and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key...to proactively partner with these roles + Accountable for clinical content for CSRs, regulatory reports, briefing… more
- AbbVie (Irvine, CA)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other ... working on the same or related programs. Experience serving as line manager to clinical development staff including Medical and/or Scientific Directors… more
- Abbott (Sylmar, CA)
- …Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management + Assist in the development of multicountry ... Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our...applicable reports and ensure appropriate responses are submitted to regulatory authorities + Evaluate proposed preclinical, clinical … more
- Abbott (Santa Clara, CA)
- …Our location in Santa Clara, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** ... to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently… more
- Cardinal Health (Sacramento, CA)
- … regulatory authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team of Specialists and manages ... matter expertise to provide services in technical writing and regulatory submissions as well as clinical research...products and develops plans for product development programs and regulatory submissions. **_Job Summary_** The Manager , … more
- Hologic (San Diego, CA)
- Manager , Regulatory Affairs (IVD) San Diego, CA, United States We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking ... for a Regulatory Affairs Manager , responsible for on-market ...+ Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance +… more
- e CancerCare (Fresno, CA)
- …Supervises staff, including Research Nurses, Clinical Research Coordinators, Regulatory Coordinators, Research Manager , and other support staff; coordinates ... Purpose: The Director, Clinical Trials & Research, for CCARE Physicians, PC,...financial activities of the department. Assures compliance with all regulatory requirements and standards of good practice (GCP) related… more