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Medical Writer I

2+ years
Not Disclosed
10 April 30, 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

Job Title: Medical Writer I
Location: India (Home-Based)
Job ID: 25003114


About the Company:
Syneos Health® is a fully integrated biopharmaceutical solutions organization, accelerating customer success by blending clinical, medical affairs, and commercial expertise to deliver modern, patient-focused outcomes. With 29,000 employees across 110 countries, Syneos Health fosters a culture where collaboration, innovation, and inclusion thrive.


Why Join Syneos Health:

  • Career growth through structured development and progression plans

  • Supportive and engaged line management

  • Recognition and total rewards programs

  • Commitment to diversity, inclusion, and “Total Self” culture


Job Responsibilities:

  • Compile, write, and edit medical writing deliverables with moderate supervision

  • Develop or support creation of documents such as:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives

    • Investigator brochures

  • Review statistical documents for grammar, format, and consistency

  • Collaborate with internal teams (data management, biostatistics, regulatory, medical affairs)

  • Adhere to regulatory standards including ICH-E3, client SOPs, and templates

  • Conduct online clinical literature searches

  • Maintain awareness of current industry regulations and medical writing trends

  • Manage time and budget efficiently for assigned projects

  • Complete administrative tasks within deadlines

  • Perform other assigned duties as required (minimal travel – less than 25%)


Qualifications:

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

  • Experience in:

    • Clinical Trial Disclosure

    • Regulatory Medical Writing

    • Pharmacovigilance (Safety Narrative Writing)

  • Familiarity with drafting CTD documents and performing quality checks

  • Preferred exposure to regulatory results posting (US FDA, ClinicalTrials.gov, EUCTR)


Additional Notes:

  • Responsibilities may be subject to change without prior notice

  • Equivalent education, skills, or experience may be considered

  • Compliance with all applicable regulations and accommodations under the ADA will be ensured