- Sumitomo Pharma (Sacramento, CA)
- …Responsibilities** + Lead cross-functional Safety Management Team (SMT) meetings to assess drug safety policies, and provide safety guidance and input to key ... Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses. + Contribute to signal… more
- MISTRAS Group, Inc. (CA)
- …client required training and security requirements. + Must maintain compliance with regulatory agency or client random drug and alcohol screening requirements. ... communication platforms. + Must successfully pass MISTRAS required motor vehicle (DMV) check, drug /alcohol test, and a background check. + Must successfully pass… more
- Ascendis Pharma (Palo Alto, CA)
- …our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially ... direction of Head of GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. This… more
- Sharp HealthCare (La Mesa, CA)
- …dose, duration, frequency, dosage form and indication.Monitors therapy for potential or actual drug interactions (eg, drug - drug , drug -disease, drug ... the patient through the following modalities:* First dose teaching* Food- drug interaction counseling* Discharge counseling* Medication classes* Compliance aidsAt… more
- Sutter Health (Santa Rosa, CA)
- …while delivering optimal patient care. **Job Description** : **JOB ACCOUNTABILITIES:** DRUG THERAPY: + Initiates, monitors, modifies and discontinues patient's ... drug therapy under the supervision of a physician in...requirements with ability to optimize procurement strategies while meeting regulatory requirements + Analyze reports/processes and the administrative functions… more
- Amgen (Thousand Oaks, CA)
- …Let's do this! Let's change the world! The Senior Engineer will join Amgen's Drug Product Process Engineering team in the Drug Product Technologies organization. ... validations to ensure execution excellence of commercial technology transfers into the drug product manufacturing facility in Thousand Oaks. The candidate will play… more
- Wells Fargo (San Francisco, CA)
- …and oversight of a wide range of documentation, ensuring alignment with regulatory requirements, internal risk frameworks, and market best practices. You will serve ... and mentor junior negotiators. Your insights into market trends and regulatory developments will help shape the firm's approach to documentation strategy… more
- AbbVie (South San Francisco, CA)
- …key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for ... drug development activities and projects to achieve departmental strategies,...quality/performance). + Provides scientific and strategic consultation to R&D, Regulatory , and all levels of management on critical decisions… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight ... Biological Product Deviation and Complaints. + Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist...Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details.… more
- Merck (South San Francisco, CA)
- …you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and ... AI/ML to support efforts in transforming the way PDMB leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused… more