- Ascendis Pharma (Palo Alto, CA)
- …+ Monitor submission deliverables as required to support investigational (IND/ CTA ) and marketing applications (BLA/NDS/MAA), and global clinical trials as ... understanding of the overall drug development process, early and late stage (IND, CTA , BLA, NDA, MAA). + Experience in participating in Regulatory filing teams with… more
- BeOne Medicines (Emeryville, CA)
- …of clinical trial design, GCP and regulatory environment for submissions (IND, CTA , NDA, BLA) + Demonstrated safety oversight skills, familiarity with DSURs, PSURs, ... and safety committees + Excellent communication skills, capable of engaging internal teams, external partners, and regulators. **Preferred** : + Proven track record in therapeutic area development (hematology or oncology) + Experience or familiar with… more
- Genentech (South San Francisco, CA)
- …trial designs + Experience supporting early-phase regulatory submissions (eg, IND, CTA ) and preparing data for downstream readiness + Demonstrated leadership in ... evolving data management practices (eg, modular CRFs, flexible standards, decentralized data sources) + Proven ability to mentor or advise study-level data managers, raising overall quality and consistency across a TA + Awareness of emerging industry practices… more
- BeOne Medicines (Emeryville, CA)
- …the authoring and review of safety sections of regulatory submissions, eg, IND/ CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, ... initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members. + Lead the authoring of Storyboards and Briefing Books for HA interactions. + Support ad-hoc review of the Safety Management Plans. + Lead Safety Science specific… more
- Deloitte (San Francisco, CA)
- …ARM/Revenue Management ) + Expertise with Intercompany, Consolidations, Multibook accounting, CTA Analysis, FX variances, and Financial Reporting + You should reside ... within a commutable distance of your assigned office with the ability to commute daily, if required + You can expect to co-locate on average 3 times a week with variations based on types of work/projects and client locations + Ability to travel up to 50%, on… more
- Deloitte (Fresno, CA)
- …to Report processes + Experience with Intercompany, Consolidations, Multibook accounting, CTA Analysis, FX variances, and/or Financial Reporting + You should reside ... within a commutable distance of your assigned office with the ability to commute daily, if required + You can expect to co-locate on average 3 times a week with variations based on types of work/projects and client locations + Ability to travel up to 50%, on… more
- AAA Northern California, Nevada & Utah (Manteca, CA)
- …and domestic travel services (preferred). + Travel Institute certification as " CTA , CTC, or CTIE" (preferred). Work Environment/Physical Requirements + Works in ... an office environment sitting at a desk, table or computer workstation for extended periods of time. + May travel by car, plane or other form of transportation to attend business meetings or conferences. + Approximately 70-80 percent of the time spent on the… more
- Stanford Health Care (San Jose, CA)
- …proper use and applications for the following imaging modalities: radiology ( CTA /PET, MRI), Echo, catheterization, carotid + ultrasound, vein and arterial mapping ... + Coordinates/triage cardiovascular hospital discharge appointments before discharge from inpatient + Monitor and report patient's lab results, blood pressure logs and weight logs for cardiac medication management + Monitor, initiate and submits electronic… more
- BeOne Medicines (Emeryville, CA)
- …Project Management Excellence** + Lead and manage complex regulatory submissions (IND/ CTA , NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, ... EU, China, and other international requirements. + Act as the (COO) to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross-functional activities are… more
- BeOne Medicines (Emeryville, CA)
- …Project Management Excellence** + Lead and manage complex regulatory submissions (IND/ CTA , NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, ... EU, China, and other international requirements. + Act as the "COO" to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross-functional activities are… more