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Sr Medical Editor (Regulatory)

2+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: BA/BS 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

 

 

Senior Medical Editor (Regulatory)
Updated: April 11, 2025
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25002456

Job Description:
Syneos Health® is a leading biopharmaceutical solutions organization, focused on accelerating customer success by translating clinical, medical, and commercial insights into actionable outcomes. We bring the customer and the patient to the center of everything we do, continuously improving to make Syneos Health easier to work with and for.

As part of our team, you’ll collaborate with passionate problem-solvers, innovating as a team to help customers achieve their goals and accelerate therapy delivery. We are agile, driven by a shared passion for changing lives.

Why Join Syneos Health:

  • Career development and progression

  • Supportive line management

  • Technical and therapeutic area training

  • Recognition and rewards programs

  • A culture that values authenticity and diversity

Key Responsibilities:

  • Maintain familiarity with FDA, EU, and other relevant guidelines to ensure documents meet or exceed regulatory requirements

  • Represent the editorial group in Medical Writing and on project teams

  • Monitor timelines and budgets, updating supervisors on potential risks

  • Provide technical support and mentorship to medical editing staff

  • Lead complex medical writing projects, ensuring information is distributed to the editorial team and executed accurately

  • Review and edit documents for grammar, punctuation, spelling, and style according to AMA or custom style guidelines

  • Conduct data integrity reviews to ensure document accuracy

  • Contribute to process improvement tools and the development of editorial policies and procedures

  • Manage projects in accordance with medical writing SOPs, ensuring timely and budget-compliant delivery

  • Compile and publish medical writing deliverables as needed

Qualifications:

  • Bachelor’s degree in life sciences, clinical sciences, English/journalism, or relevant experience

  • Significant publishing experience using Adobe Acrobat or markup languages; ISIToolbox experience preferred

  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

  • Strong copyediting, data integrity review, organizational, and project management skills

  • Familiarity with the AMA style guide

  • Knowledge of FDA and EU regulations, ICH guidelines, and ISO standards for regulatory documents preferred

  • Ability to work independently and as part of a team

  • Adaptable to changing work duties and requirements

About Syneos Health:

  • Worked with 94% of all Novel FDA Approved Drugs in the past 5 years

  • Supported 95% of EMA Authorized Products

  • Involved in 200+ studies across 73,000 sites and 675,000+ trial patients

Note:
Tasks, duties, and responsibilities are subject to change. The company may assign additional duties or alter qualifications at its discretion. This position complies with all local legislation and equal opportunity guidelines.