- Gilead Sciences, Inc. (Foster City, CA)
- …across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality , Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical ... as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +...control strategies for biologics products. + Well versed in FDA and ICH guidelines relating to registration, quality… more
- Globus Medical, Inc. (San Diego, CA)
- …to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Design and develop ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assist in the writing of regulatory applications to the FDA and other… more
- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label… more
- BeOne Medicines (San Mateo, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more
- IQVIA (San Francisco, CA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... area guidance for clinical development plans in compliance with applicable regulatory , medical, and ethics guidelines. + Ensure high- quality , data-driven… more
- Sutter Health (Santa Rosa, CA)
- …at external facilities, and in the community to provide seamless and integrated quality care + Performs one or more of the following: + Second-level controlled ... requirements with ability to optimize procurement strategies while meeting regulatory requirements + Analyze reports/processes and the administrative functions… more
- Bristol Myers Squibb (San Diego, CA)
- …+ Oversee vendors' activities, and review vendors' deliverables to ensure quality + Create/QC SDTM/ADaM data specifications, create/QC CDISC datasets and provide/QC ... clinical trial data and generating outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests + Collaborate… more
- Terumo Neuro (Aliso Viejo, CA)
- …coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties: + As ... and study training documents. + Responsible for collecting and reviewing site regulatory documents. + Manage device accountability process. + Conduct Site Initiation… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and career development + Software experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such as SAP, RIM, or ... a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director of...effort to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the monitoring,… more
- Cedars-Sinai (Los Angeles, CA)
- …with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are the Primary Duties & ... meetings. + Notifies direct supervisor about concerns regarding data quality and study conduct. + Works closely with a... and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board… more