Clinical Pharmacology Quality Control Lead

Location: Candidates must be able to work onsite at the Redwood City headquarters, with some remote flexibility available. Duration: 6 month contract (May extend or convert to permanent); open to Full-Time or Part-Time hours Compensation: Open/Competitive contract rates The Role The QC Lead performs rigorous quality control reviews of clinical pharmacology submission documents and regulatory responses. Responsibilities include ensuring: Scientific Accuracy: Verifying data points, calculations, and clinical findings. Cross-Document Consistency: Maintaining alignment across various CTD modules and regulatory filings. Submission Readiness: Preparing high-quality documentation that meets FDA/EMA expectations and internal quality standards. Regulatory Support: Assisting in the preparation and review of responses to Information Requests (IRs) from regulatory agencies. Required Skills & Qualifications Education: Advanced degree ( MS, PharmD, Ph.D., or MD ) in life sciences, pharmacy, or a related field. Submission Expertise: Strong, demonstrable experience with NDA submissions and the preparation of clinical pharmacology documents. QC Mastery: Proven expertise in the quality control of regulatory documents and a keen eye for technical detail. Regulatory Knowledge: Deep understanding of ICH guidelines , Common Technical Document ( CTD ) formats, and FDA/EMA processes. Professional Skills: Exceptional communication skills and the ability to resolve cross-functional issues under tight submission timelines. Preferred Qualifications Direct experience in oncology drug development. Prior success in supporting FDA information requests . #J-18808-Ljbffr Planet Pharma