- Humana (Sacramento, CA)
- …pharmacy knowledge a plus + Certified Coder (CPC, CRC, and/or CMC ) + Experience with metrics and reporting **Additional Information** **Work-At-Home Requirements:** ... To ensure Home or Hybrid Home/Office associates' ability to work effectively, the self-provided internet service of Home or Hybrid Home/Office associates must meet the following criteria: + At minimum, a download speed of 25 Mbps and an upload speed of 10 Mbps… more
- US Marine Corps (Oceanside, CA)
- …service hours. Recognize volunteers in accordance with established guidelines provided by CMC (MF). Recommend changes to course content to HQMC, MCFTB regarding ... specific curriculum as needed for their area of operations (AOR). Works collaboratively with DRCs/URCs to recommend courses aligned to specific unit requirements. Communicate with and educate DRCs/URCs and unit Family Readiness Command Teams to promote… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- J&J Family of Companies (San Diego, CA)
- …demonstrated expertise in applying AI/ML to drive program progression. Knowledge of CMC and Regulatory requirements is a plus. * **Leadership & Collaboration:** ... Exceptional communication skills and experience working in cross-functional, matrixed environments. Proven ability to manage strategic initiatives and lead high-performing teams. * **Technical Expertise:** Familiarity with diverse modalities including… more
- Robert Half Legal (Oakland, CA)
- …(eg, preference, consolidate), offers to compromise, case management conference ( CMC ) statements, etc.; * Prepare correspondence with clients, referring counsel, ... opposing counsel for supervising attorneys' signature; * Phone clients and treaters to update status reports; * Significant trial preparation (and even war room coordination and trial attendance for senior paralegal) work for busy trial calendar. The following… more
- Bristol Myers Squibb (San Diego, CA)
- …This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and Legal). ... **Responsibilities:** Essential duties and responsibilities include the following. Other duties may be assigned. + Provide operational expertise and lead the Investigator Initiated Trial (IIT) program with functional area oversight to ensure quality of work… more
- Aston Carter (Foster City, CA)
- …Strong computer skills and ERP system experience (SAP). + Understanding of CMC development activities for biopharmaceuticals. + Knowledge of GMP regulations (21CFR ... parts 11, 210, 211, 820). + Ability to lead cross-functional teams. + Strong people management skills. + Experience negotiating contractual agreements. + Strong verbal and written communication skills. + Ability to manage multiple programs/projects with strong… more
- Gilead Sciences, Inc. (La Verne, CA)
- …for continuous qualification of sterile production facilities. + Provides relevant CMC support for sterile products pre- and post-approval filings. + Interface ... with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team. + Assist with onboarding of new technologies and provide oversight for new qualification programs. + Work with Quality to adopt an effective quality… more
- Cardinal Health (Sacramento, CA)
- …submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use specialized ... technology and knowledge to format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though the drug product life cycle. This individual provides… more
- Astrix Technology (San Diego, CA)
- …day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); background in ... nanomedicine is a strong plus + Minimum of 3 years of QC experience in a biotech or pharmaceutical GMP environment + Prior experience in a QA department is advantageous, method validation + Hands-on expertise with techniques such as HPLC, GC, and Karl Fischer… more