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Senior Medical Writer (Redaction)

4-8 years
Not Disclosed
10 Oct. 10, 2025
Job Description
Job Type: Full Time Remote 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: 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