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Senior Medical Writer (Redaction)

4-8 years
Not Disclosed
10 Oct. 10, 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)

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.