Job Title: Senior Medical Writer (CTT & Redaction)
Updated: October 15, 2025
Location: IND – Gurugram (Hybrid)
Job ID: 25102467
Company: Syneos Health®
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical, medical affairs, and commercial expertise, the company delivers innovative solutions addressing modern healthcare challenges.
With 29,000 employees across 110 countries, Syneos Health keeps patients and customers at the center of its Clinical Development model. The organization strives to simplify processes, streamline operations, and accelerate the delivery of life-changing therapies.
Work Here Matters Everywhere.
Why Join Us
Structured career development and progression opportunities.
Supportive and engaged leadership with technical and therapeutic area training.
Recognition programs and competitive total rewards.
Inclusive “Total Self Culture” — empowering authenticity and diversity.
Collaborative global teams fostering innovation and belonging.
Position Overview
The Senior Medical Writer (CTT & Redaction) is responsible for redaction and anonymization of clinical trial documents in alignment with international disclosure regulations. The role also involves authoring and quality reviewing documents for regulatory compliance (EMA Policy 0070, Health Canada PRCI, EUCTR regulation, Final Rule–NIH).
The ideal candidate will have strong understanding of clinical trial disclosure processes, document quality control, and effective client communication skills.
Experience Required
4–8 years of experience as a medical writer, preferably with exposure to clinical trial transparency (CTT), redaction, and anonymization processes.
Key Responsibilities
1. Authoring & Quality Assurance
Execute project-specific activities within defined timelines and quality standards.
Perform redaction/anonymization of clinical documents including:
Clinical Study Reports (CSRs)
Patient Narratives
Clinical Summaries and Protocols
Other regulatory submission documents.
Review, edit, and quality-check documents per regulatory frameworks:
EMA Policy 0070
Health Canada PRCI
EUCTR Regulation
Final Rule (NIH)
Prepare protocol and results summaries to support clinical trial disclosure commitments.
Conduct systematic QC checks using pre-specified project or SOP checklists.
Analyze process outputs and ensure adherence to client-specific procedures and documentation standards.
2. Additional Responsibilities
Complete all internal and client-specific training programs.
Mentor and guide team members as required by project needs.
Participate in client communication, updates, and project reviews.
Ensure compliance with Good Clinical Practice (GCP) and disclosure guidelines.
Qualifications
Education: Minimum graduate degree in Life Sciences or related scientific discipline.
Technical Knowledge:
Understanding of clinical development processes, ICH-GCP guidelines, and disclosure regulations.
Proficiency in MS Office applications (Word, PowerPoint, Excel).
Ability to comprehend protocols and clinical study reports (CSRs) from a disclosure perspective.
Strong analytical and communication skills (written & verbal).
Core Competencies
Analytical ability to interpret scientific and clinical data.
Commitment to producing high-quality outputs with attention to detail.
Strong ownership and accountability for assigned tasks.
Proactive, enthusiastic, and team-oriented attitude.
Effective collaboration with internal and client stakeholders.
Ability to maintain professionalism and build long-term client relationships.
About Syneos Health – Global Impact
Partnered in 94% of all Novel FDA-Approved Drugs and 95% of EMA-Authorized Products over the past 5 years.
Delivered 200+ studies across 73,000 sites and 675,000+ trial patients globally.
Learn more: www.syneoshealth.com
Additional Information
Tasks and duties listed are not exhaustive; equivalent experience or education may be considered.
Syneos Health adheres to all equal opportunity employment laws and provides reasonable accommodations under the Americans with Disabilities Act (ADA).
The company values diversity, authenticity, and inclusion as part of its global culture.
Summary
The Senior Medical Writer (CTT & Redaction) plays a vital role in ensuring transparency and regulatory compliance in global clinical trials. By managing document anonymization, disclosure, and quality assurance, this position contributes directly to Syneos Health’s mission of improving patient outcomes and advancing medical innovation.
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