Senior Medical Editor (Regulatory QC Only)
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Job Description
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes that address modern market realities and improve patient care. Our Clinical Development model places the customer and patient at the center of everything we do, and we continually seek ways to simplify and streamline our work to make Syneos Health easier to work with and to work for.
Key Responsibilities
* Determine the scope of quality control review with the author and source documents/data required.
* Conduct independent quality control review of documents using an applicable checklist, ensuring accuracy of data and tables.
* Document QC review comments and deliver the checklist to the author for resolution.
* Ensure QC review documentation is completed and uploaded to applicable master files per established processes and procedures.
* Interact daily with medical writers and managers, and communicate with cross‑functional areas to provide deliverables and status updates.
* Meet project objectives and deliverables within established timelines, maintaining high quality, consistency, and accuracy. Ensure compliance with acceptance criteria for quality audits and statistical sampling plans.
Summary
Responsible for ensuring the quality of clinical regulatory submission documents by conducting quality control review utilizing checklists and ensuring documentation is provided to the applicable master files per established business processes.
Seniority Level
Mid‑Senior level
Employment type
Full‑time
Job function
Marketing, Public Relations, and Writing/Editing
Additional Information
Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may, at its sole discretion, assign additional tasks or duties. Equivalent experience, skills, and/or education may also be considered, and qualifications may differ from those listed. The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations when appropriate.
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