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Medical Writer Ii (Qc Of Regulatory Docs)

2+ years
Not Disclosed
10 July 30, 2025
Job Description
Job Type: Hybrid 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 II – QC of Regulatory Docs (Hybrid – Gurugram)

Join Syneos Health, a global biopharmaceutical powerhouse, as a Medical Writer II specializing in quality control (QC) of regulatory documents. This hybrid position based in Gurugram, India offers an exciting opportunity to work with global clients, ensure scientific accuracy in medical writing deliverables, and contribute to the advancement of clinical trials and regulatory submissions.


 Key Responsibilities

  • Perform QC of regulatory documents including CSRs, IBs, protocols, amendments, etc.

  • Write, edit, and coordinate clinical and regulatory documents independently.

  • Ensure content clarity, consistency, format, and adherence to ICH E3, AMA style, and SOPs.

  • Review statistical outputs for accuracy and consistency.

  • Lead and manage internal and client document reviews.

  • Mentor junior medical writers and review peer work.

  • Conduct clinical literature searches and ensure copyright compliance.

  • Track hours and ensure deliverables stay within budget and timelines.

  • Perform other writing-related duties as assigned.


🔹 Required Skills & Qualifications

  • Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred.

  • Minimum 2 years of experience in medical, scientific, or regulatory writing.

  • Familiarity with FDA, EMA, ICH-GCP, and medical publication guidelines.

  • Proficient in English grammar and writing; knowledge of AMA Manual of Style.

  • Experience with QC of regulatory documents (protocols, CSRs, IBs, etc.) highly desirable.

  • Strong attention to detail and ability to work independently or in teams.

  • Experience in CRO or biopharma environments preferred.


 Perks & Benefits

  • Hybrid work flexibility (Gurugram-based)

  • Career development and growth support

  • Access to global clinical and regulatory teams

  • Total rewards and peer recognition programs

  • Inclusive and diverse work environment

  • Technical and therapeutic training programs


 Company Description

Syneos Health is a leading global biopharmaceutical solutions organization operating in over 110 countries with 29,000 professionals. Known for delivering across the clinical development, regulatory, and commercial spectrum, Syneos Health accelerates drug development by translating scientific insights into impactful therapies.


 Work Mode

Hybrid – Based in Gurugram, India


 Call to Action

If you are a detail-driven regulatory writer passionate about scientific accuracy and clinical outcomes, apply today to join Syneos Health’s mission of transforming lives through clinical excellence.

Apply Now at Syneos Health Careers