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Senior Medical Writer (Ctt & Redaction)

4-8 years
Not Disclosed
10 Nov. 3, 2025
Job Description
Job Type: Full Time 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 (CTT & Redaction)

Updated:

October 15, 2025

Location:

Remote – India

Job ID:

25102467


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization working across clinical, medical affairs, and commercial sectors. The company operates in 110 countries with 29,000+ employees, having supported 94% of all FDA-approved drugs and 95% of EMA-authorized products in the past 5 years.

Syneos Health emphasizes:

  • A “Total Self” culture, valuing authenticity, diversity, and inclusion.

  • Career development and progression through training and mentorship.

  • Collaboration and innovation to accelerate drug development and delivery.

Work Here Matters Everywhere.


Position Summary

The Senior Medical Writer (CTT & Redaction) will handle clinical document redaction and anonymization for regulatory submissions under EMA Policy 0070, Health Canada PRCI, EUCTR, and NIH Final Rule.

The role involves authoring, quality review, and compliance with regulatory standards, as well as communication with global clients.


Key Responsibilities

1. Authoring and Quality Assurance

  • Prepare and review clinical documents for regulatory disclosure and publication, including:

    • Clinical Study Reports (CSRs)

    • Protocols and Results Summaries

    • Patient Narratives

    • Clinical Summaries

  • Conduct redaction/anonymization per global disclosure regulations (EMA 0070, PRCI, EUCTR, NIH Final Rule).

  • Perform QC and review using project-specific checklists and SOPs.

  • Support Clinical Trial Disclosure (CTD) through accurate and compliant documentation.

  • Maintain high-quality, timely, and consistent outputs.

2. Disclosure and Registry Support

  • Prepare and submit documents for ClinicalTrials.gov, EU Clinical Trials Register, and other registries.

  • Ensure accuracy of Protocol Registration Forms (PRF) and Results Registration Forms (RRF).

  • Interpret and summarize information from protocols and clinical study reports from a disclosure standpoint.

3. Training and Mentorship

  • Complete internal/client-specific training.

  • Mentor and support team members on disclosure and redaction processes.


Qualification Requirements

Education:

  • Bachelor’s or higher degree in Life Sciences or related field.

Experience:

  • 4–8 years of experience in Medical Writing or Clinical Trial Disclosure.

  • Strong understanding of clinical development, ICH-GCP, and regulatory submission processes.

Skills & Knowledge:

  • Expertise in regulatory requirements: EMA Policy 0070, Health Canada PRCI, EUCTR, NIH Final Rule.

  • Strong analytical and scientific writing abilities.

  • Proficiency in MS Word, PowerPoint, and Excel.

  • Clear written and verbal communication.

  • High attention to detail and quality focus.

  • Teamwork, accountability, and client relationship management.


Core Competencies

  • Analytical ability with scientific and clinical data.

  • Ownership and accountability for deliverables.

  • Commitment to quality and timelines.

  • Enthusiastic and proactive work attitude.

  • Effective team collaboration and rapport building.


Additional Information

  • Responsibilities listed are not exhaustive; additional tasks may be assigned as needed.

  • Equivalent education/experience may be considered.

  • Syneos Health complies with global equality and disability accommodation laws.


Summary

The Senior Medical Writer (CTT & Redaction) plays a vital role in ensuring compliant, transparent, and high-quality clinical document preparation for global regulatory submissions and public disclosures.