Senior Medical Writer (Redaction)

4-8 years

Not Disclosed

Gurugram

10 Oct. 19, 2025

Job Description

Job Type: Full Time Hybrid 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

Job Title: Senior Medical Writer (Redaction)

Updated: October 9, 2025
Location: IND – Gurugram (Hybrid)
Job ID: 25101577

Company Overview

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization that accelerates customer success by combining clinical development, medical affairs, and commercial expertise.

With 29,000 employees across 110 countries, Syneos Health focuses on simplifying, streamlining, and accelerating the delivery of life-changing therapies.

Motto: WORK HERE MATTERS EVERYWHERE

Why Join Syneos Health

Strong focus on career growth and development through training and mentorship.
Supportive leadership and engaging work environment.
Recognition and rewards for contributions.
Inclusive “Total Self” culture—be yourself and belong.
Collaboration across diverse global teams that bring unique perspectives together.

Position Overview

The Senior Medical Writer (Redaction) will be responsible for the redaction and anonymization of clinical documents in compliance with international disclosure and transparency regulations.

This role requires experience with EMA Policy 0070, Health Canada PRCI, EUCTR, and NIH Final Rule.
Candidates should possess strong regulatory knowledge, document quality review skills, and the ability to communicate effectively with clients and cross-functional teams.

Experience Requirement

4–8 years of experience in medical writing with hands-on exposure to redaction/anonymization.
Experience in preparing disclosure documents (Protocol Registration Form, Result Registration Form) for ClinicalTrials.gov or other registries is a plus.

Key Responsibilities

1. Authoring and Quality Assurance

Execute project-specific writing and redaction tasks with high quality and within timelines.
Redact, quality check, review, and edit regulatory documents, including:
- Clinical Study Reports (CSRs)
- Patient Narratives
- Clinical Summaries
- Protocols and other documents under disclosure regulations (EMA 0070, Health Canada PRCI, EUCTR, NIH Final Rule).
Prepare protocol and result summaries for clinical trial disclosure commitments.
Conduct quality control (QC) of documents prepared by colleagues using project-specific or SOP-based checklists.
Perform analyses of processes, outputs, and timelines.
Ensure compliance with client-specific processes and quality standards.

2. Additional Responsibilities

Complete all internal and client-specific training requirements.
Mentor and train junior team members as needed.
Support process improvement and standardization efforts across projects.

Qualifications

Education:

Minimum of a Bachelor’s degree in Life Sciences (advanced degrees preferred).

Knowledge & Skills:

Strong knowledge of regulatory requirements for disclosure/redaction.
Understanding of clinical development processes, clinical study operations, and ICH-GCP principles.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Strong ability to interpret protocols and clinical study reports from a disclosure standpoint.
Excellent written and verbal communication skills.
Good analytical, organizational, and documentation abilities.

Core Competencies

Analytical ability to interpret scientific and clinical data.
Ownership and accountability for assigned work.
Attention to detail and commitment to quality.
Effective teamwork and relationship-building skills.
Proactive, enthusiastic, and self-motivated approach.
Professional behavior in client-facing and collaborative environments.

Preferred Knowledge

Hands-on understanding of Clinical Trial Disclosure fundamentals.
Familiarity with global regulatory requirements such as:
- EMA Policy 0070 (EU transparency)
- Health Canada PRCI
- EUCTR (European Clinical Trials Regulation)
- NIH Final Rule (US disclosure regulation).

About Syneos Health

Partnered with 94% of all FDA-approved drugs and 95% of EMA-authorized products in the past 5 years.
Worked on 200+ studies across 73,000 sites and 675,000+ trial patients.
Dedicated to continuous innovation and improving patient outcomes.

🔗 Learn more: www.syneoshealth.com

Additional Information

The listed responsibilities are not exhaustive and may evolve based on project needs.
Equivalent experience and education may be considered.
Syneos Health complies with the Americans with Disabilities Act and the EU Equality Directive, ensuring reasonable accommodations where needed.

Position Summary

This role is part of the Clinical Trial Disclosure function, a key contributor to global transparency and regulatory compliance.
The Senior Medical Writer (Redaction) will process complex medical, scientific, and technical data, ensuring compliance with disclosure regulations while protecting patient privacy and proprietary information.

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Senior Medical Writer (Redaction)

Job Description

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