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Medical Writer I

0-2 years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Remote Education: 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

 

Job Title:

Medical Writer I


Company:

Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial success for biopharma companies globally.


Location:

Remote, India (Home-Based, Asia Pacific)


Job ID:

25003114


Updated:

April 30, 2025


Job Summary:

As a Medical Writer I, you will assist in compiling, writing, and editing clinical documents, working under moderate supervision. This role involves creating key regulatory and clinical trial documents, performing literature searches, collaborating across departments, and contributing to high-quality deliverables on time and within budget.


Key Responsibilities:

  • Compile, write, and edit a variety of medical documents with moderate supervision.

  • Prepare documents including:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Patient narratives

    • Investigator brochures

  • Review statistical analysis plans (SAPs) and ensure consistency and accuracy in tables/figures/listings.

  • Collaborate with teams in data management, biostatistics, regulatory affairs, and medical affairs.

  • Conduct clinical literature searches as needed.

  • Adhere to regulatory standards (e.g., ICH-E3), SOPs, and client templates.

  • Stay current with evolving regulatory guidance and client expectations.

  • Track project budgets and timelines.

  • Perform additional tasks as assigned; travel may be required (<25%).


Qualifications:

Required:

  • Postgraduate degree in Life Sciences (preferred: M.Pharm, PharmD)

  • Experience in:

    • Clinical Trial Disclosure

    • Regulatory Medical Writing

    • Pharmacovigilance, especially Safety Narrative Writing

  • Skills in drafting CTD documents and performing document quality control.

Preferred:

  • Experience with results posting to regulatory bodies (e.g., US FDA, ClinicalTrials.gov, EUCTR)


About Syneos Health:

With over 29,000 employees in 110 countries, Syneos Health has contributed to 94% of all novel FDA-approved drugs and 95% of EMA-authorized products in the past five years. The company offers flexible career paths, cross-functional collaboration, and a culture focused on innovation and inclusion.