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Medical Writer I

0-2 years
Not Disclosed
10 May 1, 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

Updated: April 30, 2025
Location: India (Home-Based, Asia-Pacific)
Job ID: 25003114
Company: Syneos Health


Position Summary

Syneos Health is seeking a Medical Writer I to contribute to the creation and quality review of clinical and regulatory documents. This entry-level writing position is ideal for life science postgraduates, especially those with a background in M.Pharm or PharmD, and offers exposure to international clinical trial documentation standards. The role supports regulatory submissions by drafting documents such as clinical study reports and investigator brochures and requires a keen eye for detail and adherence to global guidelines like ICH-E3.


Key Responsibilities

  • Write, compile, and edit a range of clinical and regulatory documents including protocols, clinical study reports, patient narratives, and investigator brochures.

  • Review statistical analysis plans and outputs to ensure clarity and consistency.

  • Collaborate with cross-functional teams such as data management, biostatistics, medical affairs, and regulatory.

  • Conduct literature searches and stay updated on evolving regulatory and writing practices.

  • Follow established internal SOPs, client-specific templates, and global regulatory writing standards (e.g., ICH, FDA, EMA).

  • Adhere to project timelines and budgets, while communicating any scope changes.

  • Perform quality control (QC) checks of CTD documents and assist with clinical trial disclosure reporting for agencies such as the US FDA and ClinicalTrials.gov.


Required Qualifications

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

  • Experience:

    • Experience or internship in regulatory medical writing, pharmacovigilance (safety narratives), or clinical trial disclosure preferred.

    • Familiarity with CTD documents and results posting for ClinicalTrials.gov, EUCTR, or similar platforms.

  • Skills:

    • Strong writing and editing skills in English.

    • Knowledge of ICH-E3 guidelines and clinical trial documentation structure.

    • Ability to work collaboratively with cross-functional teams in a remote setup.

    • Strong time management, communication, and organization skills.


Why Join Syneos Health

  • Join a global team impacting over 94% of novel FDA drug approvals in the past 5 years.

  • Develop your career in an environment that values innovation, authenticity, and growth.

  • Access training, mentorship, and continuous learning in medical writing and clinical research.