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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

Sr Medical Writer / Medical Writer 2 (Clinical Trial Transparency) – Job ID: 25001397

Updated: February 6, 2025
Location: India-Asia Pacific – IND-Home-Based, India

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By merging clinical, medical affairs, and commercial expertise, we address modern market realities and improve patient outcomes.

With 29,000 employees across 110 countries, our Total Self culture fosters an inclusive environment where every individual can thrive authentically.

Why Join Syneos Health?

  • Career development, training, and progression opportunities.
  • Supportive and engaged line management.
  • Exposure to diverse therapeutic areas and global projects.
  • Competitive total rewards program.

Job Responsibilities

  • Mentor and lead less experienced medical writers on complex projects.
  • Act as the lead writer for assigned projects.
  • Manage medical writing activities across multiple studies with minimal supervision.
  • Develop and support clinical and regulatory documents, including but not limited to:
    • Clinical study protocols & amendments
    • Clinical study reports
    • Patient narratives
    • Clinical development plans
    • IND submissions & annual reports
    • Integrated summary reports
    • NDA and (e)CTD submissions
    • Investigator brochures
    • Clinical manuscripts, abstracts, and presentations
  • Identify and resolve issues during the writing process, escalating as necessary.
  • Review statistical analysis plans for clarity, grammar, and consistency.
  • Collaborate with cross-functional teams, including data management, biostatistics, regulatory affairs, and medical affairs.
  • Conduct peer reviews of internal medical writing projects.
  • Ensure compliance with ICH-E3 guidelines, FDA/EMA regulations, company SOPs, and client standards.
  • Conduct online literature searches and stay updated on industry trends and regulatory requirements.
  • Manage project budgets and communicate necessary adjustments.
  • Complete required administrative tasks within specified timeframes.
  • Minimal travel required (less than 25%).

Qualifications & Skills

  • Education: Bachelor’s degree in Science (preferred) or Bachelor of Arts in Social Sciences, English, or Communications with relevant medical/scientific expertise.
  • Expertise in English grammar, FDA & ICH regulations, and familiarity with AMA style guide.
  • Strong ability to interpret and present clinical data with minimal supervision.
  • Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet research.
  • Excellent presentation, proofreading, and leadership skills with a team-oriented mindset.

Additional Information

  • Tasks, duties, and responsibilities listed are not exhaustive and may change at the company’s discretion.
  • Equivalent experience, skills, and education will be considered.
  • Compliance with global employment regulations, including the EU Equality Directive and Americans with Disabilities Act (ADA).