Medical Writer II (QC of Regulatory Documents) – Syneos Health, Gurgaon, India
Work Mode: On-site (Gurgaon, Haryana, India)
Compensation / Salary: Not disclosed in the job description
Job Summary
Syneos Health is seeking an experienced Medical Writer II (QC of Regulatory Docs) to quality check and author high-impact regulatory and clinical documents—including protocols, amendments, CSRs, IBs, PSURs, PBRERs, informed consents, annual reports, and plain language summaries. You will ensure scientific accuracy, consistency, template compliance, and adherence to ICH E3, ICH-GCP, FDA/EMA guidance, and AMA Manual of Style, while mentoring junior writers and partnering cross-functionally to deliver inspection-ready outputs on time and within budget.
Key Responsibilities
Perform QC/peer review of regulatory medical writing deliverables (protocols, CSRs, IBs and updates, PSUR/PBRER, narratives, PLSPs, manuscripts, abstracts, posters).
Ensure strict alignment with ICH E3, ICH-GCP, FDA/EMA guidelines, Syneos/client SOPs, and approved templates.
Coordinate and lead document reviews, manage comment resolution, and ensure traceability to source documentation.
Review SAPs, TFL shells/specifications for consistency and clarity; provide feedback to statistics teams.
Conduct comprehensive literature searches and comply with copyright requirements.
Support timeline generation, budget adherence, and status reporting to leadership.
Mentor junior writers on structure, style, compliance, timelines, and QC best practices.
Identify content/style issues and propose risk-mitigated solutions to stakeholders.
Maintain strong working knowledge of drug development, regulatory frameworks, and publishing standards.
Complete administrative tasks and documentation in accordance with organizational requirements.
Required Skills & Qualifications
Bachelor’s degree in a relevant life science discipline (Master’s/PhD preferred).
2+ years of hands-on experience in medical/regulatory writing (CRO/biopharma preferred).
Expertise in QC of protocols, CSRs, IBs, PSUR/PBRER, ICFs, narratives, and annual reports.
Solid knowledge of ICH E3, ICH-GCP, FDA/EMA guidance, eCTD Module 2, and good publication practices.
Mastery of English grammar and AMA Manual of Style.
Strong skills in MS Office; familiarity with document management and publishing systems.
Proven ability to work cross-functionally, manage multiple timelines, and deliver under pressure.
Detail-oriented with excellent analytical, editorial, and project management skills.
(While this role does not explicitly mention tools like MedDRA, GVP, ICH-GCP is referenced; ensure familiarity with clinical and safety reporting conventions when supporting PSUR/PBRER and other safety documents.)
Perks & Benefits
Structured career development and progression pathways.
Technical and therapeutic area training with peer recognition programs.
Inclusive “Total Self” culture encouraging authenticity and diversity.
Exposure to global programs across multiple therapeutic areas and regions.
Company Description
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization operating in 110 countries, partnering on 94% of all novel FDA approvals and 95% of EMA-authorized products over the past five years. The company unites clinical development, medical affairs, and commercial expertise to accelerate the delivery of life-changing therapies.
Call-to-Action
Ready to elevate your medical writing career with a global leader? Apply now and help deliver inspection-ready, submission-quality documents that move medicines to patients faster.
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