Clinical Pharmacology, Quality Control Lead

Clinical Pharmacology, Quality Control Lead

W2 Contract

Pay Rate: $90 - $100 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

We are seeking an experienced Temporary Clinical Pharmacology QC Lead to support quality control review of clinical pharmacology submission documents and regulatory responses for oncology programs in late-stage development. This role will ensure scientific accuracy, cross-document consistency, and high-quality submission-ready documentation aligned with regulatory expectations and internal standards, supporting timely responses to regulatory agencies.

Duties and Responsibilities:

• Contract position (estimated 3-6 months).
• Part-time, depending on program needs.
• Remote flexibility possible.

Requirements and Qualifications:

• Advanced degree (MS, Pharm D, Ph.D, MD, or equivalent) in life sciences, pharmacy, or related field.
• Strong experience in NDA submissions, Clinical Pharmacology, and/or clinical documents.
• Demonstrated expertise in QC of regulatory documents.
• Strong understanding of ICH guidelines, CTD format, and FDA/EMA regulatory processes.
• Excellent attention to detail and ability to work under tight timelines.
• Strong cross-functional communication and issue resolution skills.

Preferred Qualifications:

• Oncology drug development experience.
• Experience supporting FDA information requests.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.

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