- Merck (San Diego, CA)
- …Affairs Europe (RAE) and local affiliate teams. + Provide final regulatory review and approval of: + Worldwide marketing applications + Clinical study protocols ... to provide strategic regulatory input and approvals. + Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. +… more
- Edwards Lifesciences (Irvine, CA)
- …+ Support shared services and various business units with the initiation, review , redlining, and negotiation of a broad range of transactional contracts, as ... feedback from legal and business subject matter experts. + Coordinate legal review in conjunction with functional contract advisor leads (eg, corporate counsel,… more
- Stanford Health Care (Palo Alto, CA)
- …including contacting pharmacies to order prescription refills. Determine the need for physician review of prescription refills. + Be willing to be trained and use ... results, pathology results, lab work) ordered by the provider for their review . + Coordinate service requests with appropriate vendors and Stanford IT Support… more
- EMCOR Group (Palo Alto, CA)
- …that support mission-critical areas of financial services, manufacturing, pharmaceutical , transportation, and education sectors. **Job Title: Temporary Utility ... database for Action Items (Exterior Management & Transportation Services). * Visual review of areas covered during morning umbrella rounds, report to Manager any… more
- Gilead Sciences, Inc. (Foster City, CA)
- …cross-functional collaboration with departments across the company to identify, collect and review relevant records for review and production. The ideal ... product and a strong attention to detail. + Experience working in-house at a pharmaceutical or biotech company is a plus. + Experience with domestic and/or foreign… more
- Terumo Neuro (Aliso Viejo, CA)
- …FDA and ICH guidelines and other applicable regulations and guidelines. + Review and approve CDM documentation such as eCRF specifications, eCRF completion ... validation specifications, data transfer agreements and data management plans. + Review study documents, eg clinical study protocols, statistical analysis plans,… more
- Fujifilm (Santa Ana, CA)
- …Description** **Responsibilities:** + Training and supervision of all department personnel. + Review of new and completed lot folders and maintenance of all records ... and implementation of manufacturing protocols as needed. + Create, review or revise production schedules as needed. + Maintenance...+ Two years minimum experience in biological, chemical or pharmaceutical industry. + Three to five years of direct… more
- BeOne Medicines (San Mateo, CA)
- …pipeline programs and for playing a leadership role at BeOne Portfolio Review Committee (BPRC). This role will also assist with/leading certain ad-hoc ... commercial assessment/new product planning/disease area strategy/early commercialization from the pharmaceutical industry, consulting, or equity analyst roles + Oncology… more
- Astrix Technology (San Diego, CA)
- …- 95,000 **Duration:** 6-Month Contract-to-Hire **Key Responsibilities:** + Write and review study protocols and technical documentation + Perform analytical data ... review to ensure compliance with regulatory and quality standards...3 years of QC experience in a biotech or pharmaceutical GMP environment + Prior experience in a QA… more
- Astrix Technology (Gardena, CA)
- …entering data into internal systems. No lab work. **Key Responsibilities:** + Review and process batch records (non-regulated to pharmaceutical -grade materials) ... data into internal databases + Ensure compliance with cGDP standards + Generate/ review documents (eg, Certificates of Analysis) + Coordinate with labs and… more