Job Title:
Senior Medical Editor (Editing and QC of Regulatory Documents)
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model places the customer and patient at the center of everything we do. Whether in a Functional Service Provider or Full-Service environment, our teams collaborate to deliver therapies faster and improve patient outcomes.
Why Work With Us:
Career development, technical training, and mentorship opportunities.
Total Self culture promoting authenticity and inclusivity.
Recognition and rewards programs supporting personal and professional growth.
Diverse, inclusive environment fostering innovation and collaboration.
Impact:
Join 29,000 employees across 110 countries making a difference globally.
Job Responsibilities:
Maintain familiarity with FDA, EMA, and other regulatory guidelines to ensure documents meet sponsor and regulatory requirements.
Represent the editorial group in Medical Writing teams and cross-departmental projects.
Monitor project timelines and budgets; escalate risks to Lead Medical Writer, Project Manager, or supervisor.
Provide technical expertise, mentor medical editing staff, and conduct training on data integrity and editorial standards.
Lead complex medical writing projects, coordinating team meetings and distributing project-specific requirements.
Serve as part of the medical writing team, providing feedback and support during document preparation.
Copyedit documents for grammar, punctuation, spelling, style (AMA or custom guidelines), and internal checklists.
Conduct data integrity reviews to ensure accuracy of assigned documents.
Contribute to process improvement initiatives and internal editorial policies.
Manage projects in line with SOPs and client standards, ensuring timely delivery and budget adherence.
Compile and publish medical writing deliverables as required.
Qualifications:
Bachelor’s degree in Life Sciences, Clinical Sciences, English/Journalism, or equivalent publishing/editing experience.
Minimum 5+ years of experience in medical editing, copyediting, and regulatory document publishing.
Strong knowledge of editorial and publishing activities within Clinical Development.
Experience with clinical study protocols, amendments, CSRs, Investigator’s Brochures, Module 2 clinical summaries, manuscripts, posters, and abstracts.
Proficiency in Adobe Acrobat, ISIToolbox, and Microsoft Office Suite (Word, Excel, PowerPoint).
Strong attention to detail, organizational, problem-solving, communication, and project management skills.
Extensive familiarity with AMA style guide and ability to apply custom style guidelines.
Knowledge of FDA, EU requirements, ICH regulations, and ISO standards is preferred.
Ability to work independently, manage multiple projects, and adapt to changing priorities.
Additional Information:
Tasks, duties, and responsibilities are not exhaustive and may be updated at the company’s discretion.
Equivalent skills, experience, or education will be considered.
Commitment to diversity, inclusion, and accessibility in line with local and international regulations.
This format makes the JD clean, structured, and easy to scan, highlighting key sections: Overview, Responsibilities, Qualifications, and Additional Info.
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