Director of Nonclinical Regulatory Writing
Company: VirtualVocations
Location: San Francisco
Posted on: February 4, 2025
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Job Description:
A company is looking for a Director, Nonclinical Regulatory
Writing and Submission Support, Team Lead.
Key Responsibilities
Manage the nonclinical internal writing team and ensure
high-quality deliverables across all programs
Lead the planning, tracking, and regulatory compliance of
nonclinical technical and regulatory components
Develop and implement best practices and standard operating
procedures to ensure operational excellence
Required Qualifications
Ph.D. in a scientific field with a minimum of 12 years of
experience in nonclinical or scientific writing
A minimum of 3 years of managerial experience in the pharmaceutical
industry
Significant experience in authoring nonclinical summary sections
for regulatory submissions
Thorough understanding of global regulatory guidelines and
submission content
Experience with regulatory submissions for new modalities is an
advantage
Keywords: VirtualVocations, Rancho Cordova , Director of Nonclinical Regulatory Writing, Advertising , San Francisco, California
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