Instagram
youtube
Facebook

Medical Writer I

1-2 years
Not Disclosed
10 July 9, 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

 

Medical Writer I (Remote – India) | Syneos Health

Location: Remote (India)
Employment Type: Full-time
Salary Range: Not disclosed (competitive industry rate)
Company: Syneos Health
Posted Date: June 13, 2025


Job Summary:

Syneos Health is hiring a Medical Writer I to support its global medical writing operations. This is a fully remote opportunity based in India. As part of a dynamic team, you'll collaborate across clinical, regulatory, and pharmacovigilance functions to draft and edit high-quality documents including clinical trial disclosures, CTD submissions, and safety narratives. This role is ideal for candidates with a postgraduate degree in life sciences and experience in regulatory or clinical writing.


Key Responsibilities:

  • Draft and edit documents such as clinical study protocols, study reports, amendments, investigator brochures, and patient narratives

  • Support Clinical Trial Disclosure and CTD document submissions

  • Review statistical analysis plans, tables, listings, and figures for clarity and accuracy

  • Perform quality checks on peer documents to ensure regulatory and editorial compliance

  • Conduct clinical literature searches as required

  • Ensure compliance with ICH-E3 guidelines, regulatory standards, SOPs, and client-approved templates

  • Coordinate with biostatistics, data management, regulatory, and clinical teams to ensure timely document delivery

  • Support safety narrative writing in pharmacovigilance projects

  • Stay current with industry trends, regulations, and medical writing best practices


Required Skills & Qualifications:

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

  • 1–2 years of experience in medical writing or related clinical trial document preparation

  • Familiarity with Clinical Trial Disclosure, Regulatory Medical Writing, and Pharmacovigilance (Safety Narratives)

  • Understanding of global regulatory requirements and ICH guidelines

  • Experience with platforms such as ClinicalTrials.gov, EUCTR, or results posting for FDA

  • Proficiency in Microsoft Office Suite and relevant collaborative tools

  • Excellent written and verbal communication skills in English

  • Detail-oriented with strong organizational and time management skills


Perks & Benefits:

  • 100% remote work flexibility (India-based)

  • Career development and internal growth opportunities

  • Supportive and inclusive work culture

  • Comprehensive technical and therapeutic training

  • Recognition programs and competitive compensation

  • Access to global clinical research expertise and resources


About Syneos Health:

Syneos Health is a global biopharmaceutical solutions organization helping customers accelerate the development and commercialization of therapies. With a footprint in over 110 countries and partnerships on 94% of novel FDA-approved drugs in the last 5 years, Syneos is a leader in clinical, medical affairs, and commercial delivery across the drug development lifecycle.


Work Mode: Remote (India)


Call to Action:

Are you ready to shape the future of clinical research with your medical writing expertise? Apply now to become a Medical Writer I at Syneos Health and make a lasting impact in healthcare and drug development.