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Senior Medical Writer (Ctt & Redaction)

4-8 years
Not Disclosed
10 Oct. 19, 2025
Job Description
Job Type: Full Time Remote 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: Remote – India
🆔 Job ID: 25102467


Company Overview

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

Culture & Values:

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

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

  • Focus on collaboration, innovation, and agility to improve therapy delivery and client outcomes.

Global Impact:

  • Worked with 94% of novel FDA-approved drugs and 95% EMA-authorized products.

  • Conducted 200+ studies across 73,000+ sites involving 675,000+ trial patients.


Job Purpose

Responsible for Clinical Trial Disclosure (CTD) and redaction/anonymization of clinical documents in preparation for regulatory submissions, ensuring quality, compliance, and adherence to timelines. Supports high-performing teams in processing complex scientific, medical, and technical information.


Key Responsibilities

Authoring & Quality Assurance

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

    • Clinical Study Reports (CSRs)

    • Patient Narratives

    • Clinical Summaries

    • Protocol & Results Summaries

  • Perform redactions/anonymizations per regulations:

    • EMA Policy 0070

    • Health Canada PRCI

    • EUCTR Regulation

    • Final Rule – NIH

  • Systematic quality checks on colleagues’ documents against project-specific checklists or SOPs.

  • Conduct detailed analyses on processes and document outputs.

  • Ensure compliance with client-specific processes.

Clinical Trial Disclosure Support

  • Prepare disclosure documents for ClinicalTrials.gov and other registries (Protocol Registration Form, Results Registration Form).

  • Understand and interpret protocols and CSRs from a disclosure perspective.

  • Maintain knowledge of clinical trial disclosure fundamentals.

Team Support & Additional Activities

  • Complete internal and client-specific training.

  • Assist in mentoring and training junior team members.


Qualifications & Experience

  • Education: Scientific graduate degree in Life Sciences.

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

  • Technical Skills:

    • Proficient in MS Word, PowerPoint, Excel.

    • Strong written and verbal communication skills.

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

  • Regulatory Knowledge: Familiarity with EMA, Health Canada, NIH, EUCTR disclosure regulations.


Core Competencies

  • Strong analytical skills with scientific and clinical data.

  • High attention to detail and commitment to quality outputs.

  • Professionalism, ownership, and proactivity.

  • Effective team working and ability to build client rapport.


Additional Information

  • Responsibilities may evolve; the company may assign additional tasks as needed.

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

  • Compliant with the Americans with Disabilities Act; reasonable accommodations provided.

  • Opportunity to join the Talent Network for future career opportunities.


Summary

The Senior Medical Writer (CTT & Redaction) ensures accurate and compliant disclosure of clinical trial data. The role involves handling complex scientific, medical, and technical information while maintaining quality, regulatory adherence, and supporting team collaboration.

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