- Astellas Pharma (San Diego, CA)
- …CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good ... in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific… more
- AbbVie (Irvine, CA)
- …submission-related studies (ISO 10993), performing life cycle compliance -related activities, and developing scientific messaging for advertising/promotional ... / Responsibilities SCIENTIFIC LEADERSHIP + Function as a principle investigator /lead, generating original technical ideas and research or development strategies.… more
- Rincon Consultants (Sacramento, CA)
- …Maintain QAQC of various cultural resource work products that support CEQA and NEPA compliance for various agencies, as well as regulatory and permit compliance ... + Qualifies as Bureau of Land Management Field Director and/or Principal Investigator + Experience working under the direction of an environmental planner +… more
- Kelly Services (South San Francisco, CA)
- …Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for adverse event (AE) reporting, and ... PD, and MM Plan. + Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and our client's standards. + Provide support for… more
- Stanford University (Stanford, CA)
- …and submit new applications according to CFR 21 Part 312 including Investigator New Drug (IND) applications, revisions, amendments, and Informed Consent documents in ... as required. + Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory...regulations as well as university policies to ensure optimal compliance . + Serve as primary liaison on safety issues… more
- Pfizer (Sacramento, CA)
- …Conduct all activities in accordance with all relevant policies, procedures and compliance guidance + Educate external medical stakeholders based on patient care ... researchers as appropriate + Appropriately provide Medical support throughout the Investigator Sponsored Research (ISR) process + Cultivate research and therapeutic… more
- University of Southern California (Los Angeles, CA)
- …and feasibility of required study tests, at areas pertaining to patient compliance , dose modification and at drug toxicities. At times will provide information ... patients. f. Follows CISO SOPs II. Patient Care Related A. Physician/ Investigator Interaction 1. Discusses patient eligibility questions and any patient concerns.… more
- Stanford Health Care (Palo Alto, CA)
- …within Stanford Health Care's governance and standards to uphold regulatory compliance , quality, and patient-first care while enabling groundbreaking research. What ... and related orders according to protocol specs provided by the Principal Investigator (PI) and CRC study/validation teams. * Collaborate with nurses, pharmacists,… more
- Sun Pharmaceuticals, Inc (Los Angeles, CA)
- …and ensure they are updated on new data + Respond to requests for investigator sponsored research (ISS) proposals and transit them into Sun and present the research ... + Respond to scientific inquires consistent with the MSL compliance standards, + Foster scientific relationships between SUN and...others + Comply with all applicable SUN Health Care Compliance SOPs and US regulations Qualifications: + Doctorate /… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …of our innovative cell therapies, ensuring patient safety, regulatory compliance , and scientific excellence across the product lifecycle. **Key Responsibilities** ... + Serve as the primary author of safety sections in protocols, Investigator 's Brochures, CSRs, DSURs, RMPs, and regulatory documents/responses. + Represent Drug… more