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Senior Medical Writer (Ctt & Redaction)

4-8 years
Not Disclosed
10 Oct. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Senior Medical Writer (CTT & Redaction)

📅 Updated: October 15, 2025
📍 Location: Gurugram – Hybrid
🆔 Job ID: 25102467


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by leveraging clinical, medical affairs, and commercial insights.

Culture & Values:

  • Career development, technical/therapeutic training, peer recognition, and total rewards.

  • Total Self culture: encourages authenticity, inclusion, and belonging.

  • Promotes collaboration, creativity, and agility to improve therapy delivery and client outcomes.

Impact Statistics:

  • Worked with 94% of novel FDA-approved drugs, 95% EMA-authorized products, over 200 studies, across 73,000 sites, involving 675,000+ trial patients.


Job Purpose

The Senior Medical Writer focuses on Clinical Trial Disclosure (CTD) and redaction/anonymization of clinical documents in preparation for various regulatory requirements. This role ensures quality, compliance, and adherence to timelines while supporting complex, scientific, medical, and technical information projects.


Key Responsibilities

Authoring & Quality Assurance

  • Author, QC, and edit clinical study documents, including:

    • Clinical Study Reports (CSRs)

    • Patient Narratives

    • Clinical Summaries

    • Protocol and Results Summaries

  • Ensure compliance with regulatory requirements:

    • EMA Policy 0070

    • Health Canada PRCI

    • EUCTR Regulation

    • Final Rule – NIH

  • Conduct systematic quality control checks on documents prepared by colleagues using project-specific checklists or SOPs.

  • Perform detailed analyses on planned and ad hoc basis relating to processes and outputs.

  • Ensure adherence to client-specific processes and project timelines.

Clinical Trial Disclosure Support

  • Prepare disclosure documents such as Protocol Registration Form and Results Registration Form for ClinicalTrials.gov and other registries.

  • Comprehend protocol and CSR content from a disclosure perspective.

  • Understand clinical trial disclosure fundamentals and requirements.

Team Support & Additional Activities

  • Complete internal and client-specific training.

  • Mentor and support junior team members based on project requirements.


Qualifications & Experience

  • Education: Scientific graduate degree in Life Sciences.

  • Experience: 4–8 years in medical writing, preferably in CTD and redaction/anonymization.

  • Technical Skills:

    • Knowledge of ICH-GCP guidelines and clinical development processes.

    • Proficiency in MS Word, PowerPoint, Excel.

    • Strong written and verbal communication skills.

  • Regulatory Knowledge:

    • Familiarity with EMA, Health Canada, NIH, and EUCTR regulations related to clinical trial disclosure.


Core Competencies

  • Analytical capabilities with scientific and clinical data.

  • Commitment to highest quality outputs and attention to detail.

  • Professionalism and ownership of allocated work.

  • Enthusiasm, proactivity, and effective team working.

  • Ability to build rapport with project-specific client colleagues.


Additional Information

  • Tasks and responsibilities are not exhaustive; may be updated at company discretion.

  • Equivalent experience, skills, and education may be considered.

  • Compliant with legislation, including the Americans with Disabilities Act for reasonable accommodations.

  • Opportunity to join the Talent Network to stay connected with future career opportunities.


Summary

The Senior Medical Writer (CTT & Redaction) plays a critical role in executing clinical trial disclosure projects for Syneos Health’s global clients. The role requires meticulous handling of complex scientific, medical, and technical information while maintaining high quality, compliance, and adherence to timelines.

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