Job Title:
Senior Medical Writer (Redaction)
Location: Gurugram, India (Hybrid)
Job ID: 25101577
Updated: Yesterday
Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating clinical, medical affairs, and commercial insights into actionable outcomes, we address modern market realities.
Why Work Here:
Career development and progression opportunities
Supportive line management and mentoring
Technical and therapeutic training programs
Peer recognition and rewards programs
Inclusive Total Self culture encouraging authenticity
Vision: Simplifying processes and accelerating delivery of therapies while putting patients and customers at the center.
Job Summary:
The Senior Medical Writer (Redaction) will focus on redaction/anonymization of clinical documents for regulatory submissions, ensuring compliance with EMA Policy 0070, Health Canada PRCI, EUCTR regulation, and NIH Final Rule. This role requires strong understanding of clinical trial disclosure requirements and ability to produce high-quality, accurate documents.
Experience Required: 4–8 years in medical writing with clinical trial disclosure focus.
Key Responsibilities:
1. Authoring and Quality Assurance of Project Activities
Execute project-specific activities with high quality and within defined timelines.
Redact and review clinical documents, including:
Clinical Study Reports (CSRs)
Patient narratives
Clinical summaries for regulatory submissions
Protocol and results summaries for clinical trial disclosure commitments
Perform systematic quality control (QC) checks on documents prepared by colleagues against pre-specified checklists or SOPs.
Analyze processes and outputs on planned and ad hoc basis.
Ensure compliance with client-specific processes.
2. Additional Activities
Complete internal and client-specific training.
Mentor and train junior team members as required.
Qualifications & Skills:
Educational: Scientific graduate degree in Life Sciences
Knowledge & Experience:
Regulatory requirements for clinical trial disclosure (EMA, Health Canada, NIH, EUCTR)
Clinical development processes and ICH-GCP guidelines
Clinical trial disclosure fundamentals
Technical Skills: MS Word, PowerPoint, Excel
Core Competencies:
Analytical skills with scientific/clinical data
Attention to detail and commitment to quality
Professionalism and ownership of work
Effective teamwork and client relationship management
Proactive and enthusiastic approach
Additional Information:
Responsibilities may include additional tasks as required by the company.
Equivalent experience, skills, and education may be considered.
This job description does not create an employment contract.
Compliance with local and international regulations, including ADA provisions for reasonable accommodations.
Why Syneos Health:
Work on challenging assignments processing complex scientific, medical, and technical information
Contribute to high-performing teams supporting global clients
Engage in a collaborative and innovative work environment
Learn More: www.syneoshealth.com
Application:
Apply now or join the Talent Network to stay connected with future opportunities.
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