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Senior Medical Editor (Editing And Qc Of Regulatory Docs)

5 years
Not Disclosed
10 Sept. 10, 2025
Job Description
Job Type: Hybrid Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.