Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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 focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into 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.


Job Purpose

Responsible for clinical trial disclosure, including redactions/anonymization of documents for regulatory compliance. Works on high-quality deliverables, supports client communications, and mentors junior writers.


Key Responsibilities

Authoring & Quality Assurance

  • Redact/anonymize clinical documents for regulations (EMA Policy 0070, Health Canada PRCI, EUCTR, NIH Final Rule).

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

  • Review and edit:

    • Clinical study reports

    • Patient narratives

    • Clinical summaries

    • Protocols and results summaries

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

  • Conduct detailed analyses of processes and outputs.

  • Ensure adherence to client processes and project 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 strong understanding of clinical trial disclosure fundamentals.

  • Knowledge & Skills:

    • Regulatory requirements and guidance for the service line.

    • Clinical development processes, ICH-GCP guidelines.

    • Proficient in MS Word, PowerPoint, Excel.

    • Clear 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 as needed.

  • 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.