Job Title:
Senior Medical Editor (Regulatory)
Company:
Syneos Health
A global leader in biopharmaceutical solutions committed to accelerating the delivery of therapies by providing integrated clinical, medical affairs, and commercial services.
Location:
Home-Based, India (Asia Pacific - IND)
Job ID:
25002456
Updated:
April 27, 2025
Job Summary:
The Senior Medical Editor (Regulatory) will lead the editorial process for regulatory documents, ensuring compliance with industry guidelines, including FDA, EU, and ICH regulations. The role involves managing the quality of medical writing deliverables, mentoring junior team members, and driving the continuous improvement of internal processes.
Key Responsibilities:
Ensure documents comply with FDA, EU, and other regulatory guidelines, addressing sponsor and regulatory requirements.
Represent the editorial group in medical writing teams and project teams.
Manage project timelines, budgets, and internal communication, ensuring project deliverables are on schedule.
Provide editorial guidance and training to medical editors and writers, ensuring high-quality standards in medical writing and editing.
Lead complex medical writing projects, coordinating with cross-functional teams.
Perform detailed copyediting, ensuring accuracy in grammar, punctuation, style, and consistency with AMA or other applicable style guides.
Conduct data integrity reviews to ensure accuracy in the documents.
Contribute to the development of process improvement tools and revise editorial policies.
Lead the compilation and publication of medical writing deliverables.
Manage projects according to medical writing SOPs, ensuring timely and budget-compliant delivery.
Qualifications:
Required:
Bachelor’s degree in life sciences, clinical sciences, or English/journalism, or equivalent experience in medical editing and publishing.
Significant experience in publishing, with proficiency in Adobe Acrobat, ISIToolbox, or other relevant markup languages.
Strong skills in Microsoft Office Suite (Word, Excel, PowerPoint).
Excellent attention to detail, with a focus on data integrity, accuracy, and problem-solving.
Familiarity with the AMA style guide and regulatory guidelines (FDA, EU, ICH).
Ability to work independently and as part of a team, managing multiple assignments with set deadlines.
Preferred:
Experience in regulatory document editing for clinical trials and related submissions.
Knowledge of FDA, EU, and ISO standards applicable to regulatory documents.
Why Syneos Health?
Syneos Health offers an environment that fosters growth and innovation. Employees are encouraged to bring diverse perspectives to the table, creating a culture of collaboration and success.
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