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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: India – Remote
🆔 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, technical/therapeutic training, peer recognition, and total rewards.

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

  • 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.


Role Purpose

Responsible for clinical trial disclosure, including redaction/anonymization of clinical documents, supporting regulatory compliance, performing quality reviews, client communication, and mentoring junior writers.


Key Responsibilities

Authoring & Quality Assurance

  • Redact/anonymize clinical documents according to:

    • EMA Policy 0070

    • Health Canada PRCI

    • EUCTR regulations

    • NIH Final Rule

  • Prepare disclosure documents for clinical registries (e.g., clinicaltrials.gov).

  • Review, QC, and edit:

    • Clinical study reports

    • Patient narratives

    • Clinical summaries

    • Protocols and results summaries

  • Perform systematic QC checks against project-specific checklists or SOPs.

  • Conduct detailed analyses related to processes and outputs.

  • Ensure compliance with client processes and timelines.

Mentorship & Training

  • Assist in mentoring and training team members as required.

  • Complete internal and client-specific trainings.

Client & Project Communication

  • Maintain effective communication with client teams.

  • Build rapport and relationships with project-specific client colleagues.


Qualifications & Experience

  • Education: Scientific graduate degree in life sciences.

  • Experience: 4–8 years in medical writing with a focus on clinical trial disclosure.

  • Knowledge & Skills:

    • Regulatory requirements relevant to the service line.

    • Clinical development processes, ICH-GCP guidelines.

    • Proficiency in MS Word, PowerPoint, Excel.

    • Strong written and verbal communication.

    • Ability to interpret protocols and clinical study reports from a disclosure perspective.


Core Competencies

  • Analytical capabilities with scientific and clinical data.

  • Professional work environment and ownership of work.

  • Commitment to high-quality outputs and attention to detail.

  • Enthusiasm, proactivity, and effective team collaboration.


Additional Information

  • Responsibilities may evolve; company may assign additional tasks.

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

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

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


Summary

The Senior Medical Writer (CTT & Redaction) plays a critical role in clinical trial disclosure projects, executing complex scientific, medical, and technical assignments while ensuring compliance, quality, and mentorship within high-performing teams.