Medical Writer Ii

1+ years
Not Disclosed
10 March 24, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Medical Writer II – Home-Based, India
 

Overview:
Syneos Health® is seeking a Medical Writer II to compile, write, and edit medical writing deliverables with minimal supervision, ensuring compliance with regulatory standards and client expectations.

Key Responsibilities:

  • Mentor less experienced medical writers as needed.

  • Develop and edit various clinical documents, including:

    • Clinical study protocols and amendments.

    • Clinical study reports.

    • Patient narratives.

    • Annual reports.

    • Investigator brochures.

  • Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency.

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

  • Serve as a peer reviewer, ensuring scientific content, clarity, and consistency.

  • Adhere to ICH-E3 guidelines, company SOPs, and client-approved templates.

  • Conduct online clinical literature searches as applicable.

  • Manage projects within budgeted hours and communicate changes to leadership.

  • Perform other related duties as assigned.

Qualifications:

  • Minimum 1 year of experience in drafting and reviewing narratives.

  • Postgraduate (Master’s/MPharm) or Bachelor’s degree required.

  • Extensive knowledge of English grammar, FDA, and ICH regulations.

  • Familiarity with AMA style guide.

  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

  • Ability to interpret and present clinical data and complex information.

  • Strong leadership, presentation, and proofreading skills.

Additional Information:

  • Minimal travel required (less than 25%).

  • Syneos Health has contributed to 94% of all FDA-approved drugs and 95% of EMA-authorized products over the past 5 years.

Location: Home-Based, India
Updated: March 20, 2025
Job ID: 25002303