- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... interactions with PCM Governance at pre-specified milestones and as program issues or opportunities arise. + Has a deep...PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. +… more
- Genentech (South San Francisco, CA)
- …Leadership Team to ensure that the study start-up strategy aligns with GCP and regulatory requirements. As the leader of the PDG US Country Study Start-Up Team, the ... improvements at both the country and site levels, all while maintaining regulatory compliance. This position is central to optimizing our country operations and… more
- AbbVie (Irvine, CA)
- …of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- Danaher Corporation (San Diego, CA)
- …SW96, and CLSI AUTO11-Ed3) + Experience with cross-functional collaboration (eg Engineering, Quality Affairs , Regulatory Affairs , Program Management, and ... cancer diagnostics and improve lives. This role reports to the Senior Manager , Software Engineering, and will focus on product lifecycle security, including threat… more
- Bristol Myers Squibb (San Diego, CA)
- … program action items and deliverables in collaboration with project leads and program manager + Prepare and process expense reports, memberships, PO's and ... communication related to vivarium operations + Assist with projects involving Medical Affairs , Clinical Development, Regulatory , and other departments. + Track… more
- Vera Therapeutics (Brisbane, CA)
- …representative to the company, overseeing and evolving Vera's Healthcare Compliance Program . Responsibilities: Training & Policy Development * Develop, execute, and ... oversee Vera's Compliance Program , in partnership with Vera Legal, including drafting relevant...to employees, ensuring understanding of industry-specific compliance risks and regulatory obligations. * Monitor evolving federal and state compliance… more
- BeOne Medicines (San Mateo, CA)
- …mentorship to regional clinical study managers & regional clinical trial manager associates/clinical trial associates at various levels for assigned portfolio and ... lead a designated therapeutic area or asset + Line manager to Associate Directors in the team + Accountable...the region to senior management and Global Study and Program team as required.** + **Forms high impact, cross-departmental… more
- Stanford University (Stanford, CA)
- …manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs , quality systems, business & administration; ... maintain regular reporting to functional manager . + Develop methods for, perform, and supervise manufacturing...duties and responsibilities may vary depending on department or program needs without changing the general nature and scope… more
- Philips (San Diego, CA)
- …collaborate with cross-functional stakeholders, including Marketing, Medical Education, Sales, Legal, Regulatory Affairs , and Clinical teams, to drive process ... Enablement, or similar tools; experience with information systems related to platform/ program manager in IT + You bring strong technical, process optimization,… more
- Guardian Life (Sacramento, CA)
- …We drive a high-performance culture across our Legal, Compliance, and Government Affairs functions, aligned to "what" we deliver (ie, our goals and objectives) ... environment in the branch office. + Timely communicate preliminary findings to your manager and branch office management verbally and then in writing. + Assist, as… more
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