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Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: BA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

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Senior Medical Writer (Clinical Trial Transparency) – Job ID: 25001397-IND501

Location: India-Asia Pacific – IND-Gurugram-DLF Downtown
Updated: February 6, 2025

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model places the customer and patient at the core, fostering collaboration to drive innovation and efficiency in delivering life-changing therapies.

With 29,000 employees across 110 countries, we embrace a Total Self culture, promoting career growth, diversity of thought, and an inclusive work environment where everyone belongs.

Why Join Syneos Health?

  • Career development, training, and progression opportunities.
  • Supportive management and peer recognition programs.
  • Exposure to a wide range of therapeutic areas and global projects.
  • Competitive total rewards program.

Job Responsibilities

  • Lead and mentor junior medical writers on complex projects.
  • Manage medical writing activities for assigned studies, ensuring coordination across departments.
  • Develop and support key regulatory and clinical documents, including:
    • Clinical study protocols & amendments
    • Clinical study reports
    • Patient narratives
    • Clinical development plans
    • IND submissions & annual reports
    • NDA and (e)CTD submissions
    • Investigator brochures
    • Clinical manuscripts, abstracts, and presentations
  • Identify and resolve challenges in the writing process, escalating when needed.
  • Review statistical analysis plans for accuracy, grammar, and consistency.
  • Act as a liaison between medical writing, data management, biostatistics, regulatory, and medical affairs teams.
  • Provide peer reviews for clarity, accuracy, and regulatory compliance.
  • Conduct online literature searches and stay updated on industry regulations.
  • Ensure projects are delivered on-time and on-budget while adhering to ICH-E3 guidelines, FDA/EMA regulations, and company SOPs.
  • Manage project budgets and communicate necessary adjustments.
  • Complete administrative tasks within designated timeframes.

Qualifications & Skills

  • Bachelor’s degree in Science or relevant writing experience (preferred: English, Social Sciences, or Communications with medical/scientific knowledge).
  • Strong command of English grammar and familiarity with AMA style guide, FDA, and ICH regulations.
  • Proven ability to interpret and present complex clinical data with minimal supervision.
  • Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet research.
  • Effective presentation, proofreading, and leadership skills with a team-oriented approach.

Additional Information

  • Minimal travel required (less than 25%).
  • Tasks and responsibilities are subject to change at the company’s discretion.
  • Syneos Health complies with global employment regulations, including the EU Equality Directive and Americans with Disabilities Act (ADA) for reasonable accommodations.