Job Title:
Senior Medical Writer (Redaction)
Location: Remote, India
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 outcomes, we address modern market realities.
Why Syneos Health:
Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic area training programs
Peer recognition and total rewards
Inclusive Total Self culture encouraging authenticity and belonging
Vision: Simplifying processes and accelerating delivery of therapies while keeping patients and customers at the center.
Job Summary:
The Senior Medical Writer (Redaction) will focus on redaction and anonymization of clinical documents to meet various regulatory requirements including EMA Policy 0070, Health Canada PRCI, EUCTR regulation, and NIH Final Rule. The role involves high-quality authoring, quality control, client communication, and compliance with clinical trial disclosure standards.
Experience Required: 4–8 years in medical writing, preferably with clinical trial disclosure experience.
Key Responsibilities:
1. Authoring and Quality Assurance
Redact, review, and edit clinical documents for regulatory submission:
Clinical Study Reports (CSRs)
Patient narratives
Clinical summaries
Protocol and results summaries for disclosure commitments
Ensure quality control of documents prepared by colleagues using pre-specified checklists or SOPs
Execute project-specific activities with accuracy and within defined timelines
Perform detailed planned and ad hoc analyses on project outputs
Follow client-specific processes and SOPs
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 capabilities with scientific and clinical data
Attention to detail and commitment to quality
Professionalism and ownership of work
Team collaboration and client relationship management
Enthusiastic, proactive, and high-quality output focused
Additional Information:
Job responsibilities are not exhaustive; 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
About the Role:
Works on high-performing teams processing complex scientific, medical, and technical information
Supports global clients in executing Clinical Trial Disclosure projects
Contributes to high-quality, regulatory-compliant documentation
Learn More: www.syneoshealth.com
Application:
Apply now or join the Talent Network to stay connected with future opportunities
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