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Sr Medical Writer (Redaction)

4-8 years
Not Disclosed
10 April 3, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 


Senior Medical Writer (Redaction)

Company: Syneos Health
Location: India
Experience: 4-8 years

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions company, focused on clinical development, medical affairs, and commercial success. With 29,000 employees across 110 countries, Syneos Health is committed to accelerating therapy development and making an impact in the healthcare industry.

Join us—because work here matters everywhere.


Job Summary

The Senior Medical Writer (Redaction) will be responsible for redaction and anonymization of clinical study documents in preparation for regulatory submissions across various global agencies (EMA Policy 0070, Health Canada PRCI, EUCTR, NIH Final Rule). This role involves quality assurance, client communication, and project management to ensure compliance with disclosure regulations.


Key Responsibilities

Document Redaction & Disclosure Compliance

  • Redact/anonymize regulatory documents, including:

    • Clinical Study Reports (CSRs)

    • Patient Narratives

    • Clinical Summaries

    • Protocol and results summaries for clinical trial disclosures

  • Ensure adherence to global disclosure regulations (EMA Policy 0070, Health Canada PRCI, EUCTR, NIH Final Rule).

  • Perform Quality Control (QC) checks on documents following standard operating procedures (SOPs) and regulatory guidelines.

  • Conduct detailed analyses and reviews of clinical trial documents for public disclosure.

Quality Assurance & Client Communication

  • Review and edit documents to ensure regulatory compliance and high-quality standards.

  • Systematically perform quality control checks against project-specific checklists.

  • Collaborate with internal teams and external clients for feedback and process improvement.

  • Ensure compliance with client-specific processes and requirements.

Training & Mentorship

  • Assist in mentoring and training team members on document redaction and disclosure guidelines.

  • Participate in internal and client-specific training programs to stay updated on evolving regulations.


Qualifications & Skills

Education & Experience

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.

  • 4-8 years of experience in medical writing, redaction, or clinical document disclosure.

  • Prior experience in clinical research, regulatory writing, or drug development is preferred.

Technical & Regulatory Knowledge

  • Strong understanding of clinical trial disclosure fundamentals.

  • Knowledge of clinical trial development, ICH-GCP guidelines, and regulatory submission requirements.

  • Experience in clinical registry submissions (e.g., ClinicalTrials.gov).

  • Proficiency in Microsoft Word, Excel, PowerPoint and other documentation tools.

Soft Skills

  • Strong analytical skills to interpret scientific and regulatory information.

  • Excellent written and verbal communication for document review and client interactions.

  • Ability to work independently and in a team-oriented environment.

  • Attention to detail and commitment to high-quality deliverables.


Why Join Syneos Health?

  • Worked with 94% of all Novel FDA-Approved Drugs in the past 5 years.

  • Collaborated on 95% of EMA-Authorized Products and 200+ studies across 73,000 sites.

  • Competitive career growth, mentorship, and rewards program.

  • Be part of a diverse, inclusive, and innovative workplace.


Join Us

If you have relevant experience, we encourage you to apply now or join our Talent Network for future opportunities at Syneos Health.

 

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