Sr Medical Writer (Redaction)

4-8 years

Not Disclosed

India

10 March 31, 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)

📍 Location: India-Asia Pacific - IND-Home-Based
📌 Job ID: 25002334
📅 Updated: March 26, 2025

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating drug development and bringing life-changing therapies to market. With a presence in 110 countries and 29,000+ employees, we deliver insights-driven solutions to improve patient outcomes globally.

Job Overview

As a Senior Medical Writer (Redaction), you will play a crucial role in ensuring clinical trial transparency by performing redaction and anonymization of clinical documents for regulatory submission. You will ensure compliance with global regulatory requirements (EMA Policy 0070, Health Canada PRCI, EUCTR, NIH Final Rule) and contribute to the preparation of clinical trial disclosure documents.

Key Responsibilities

Medical Writing & Clinical Trial Transparency

✔ Author, review, and perform redaction/anonymization of clinical study documents for regulatory submissions.
✔ Work on documents including clinical study reports (CSRs), patient narratives, clinical summaries, and regulatory submission materials.
✔ Ensure compliance with international regulations (EMA, FDA, Health Canada, NIH, EUCTR).
✔ Support the preparation of clinical trial disclosure documents (e.g., Protocol Registration Form, Results Registration Form for ClinicalTrials.gov and other registries).

Quality Control & Compliance

✔ Conduct quality assurance (QA) reviews of redacted documents based on client-specific guidelines and regulatory standards.
✔ Perform systematic quality control (QC) checks to ensure accuracy and completeness.
✔ Maintain detailed documentation to support audit readiness and compliance.

Collaboration & Client Communication

✔ Work closely with cross-functional teams (clinical, regulatory, and biostatistics).
✔ Communicate effectively with clients and regulatory authorities regarding document requirements.
✔ Provide expert guidance on redaction and anonymization processes.

Training & Mentorship

✔ Assist in training and mentoring junior medical writers.
✔ Stay updated on industry trends, regulatory changes, and best practices in clinical trial disclosure.

Qualifications & Skills

🎓 Education:
🔹 Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.

💡 Experience & Technical Skills:
✔ 4-8 years of medical writing experience with a strong focus on redaction and anonymization.
✔ In-depth knowledge of global regulatory requirements (EMA Policy 0070, Health Canada PRCI, EUCTR, NIH Final Rule).
✔ Experience in preparing disclosure documents for ClinicalTrials.gov and other registries (preferred).
✔ Familiarity with CTT databases (Disclose, Prime, PRS, EudraCT) is a plus.
✔ Proficiency in Microsoft Word, Excel, PowerPoint.

🗣 Soft Skills:
✔ Strong analytical and critical-thinking skills.
✔ Excellent written and verbal communication skills.
✔ High attention to detail and commitment to quality.
✔ Ability to work independently and in collaborative, deadline-driven environments.

Why Join Syneos Health?

🔹 Work on 94% of FDA-approved drugs in the past five years.
🔹 Career growth with technical training, mentorship, and leadership opportunities.
🔹 Collaborative and innovative Total Self culture that values diversity and inclusion.

💼 Apply Today!
Join Syneos Health and contribute to global clinical trial transparency efforts.

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Sr Medical Writer (Redaction)

Job Description

Senior Medical Writer (Redaction)

About Syneos Health

Job Overview

Key Responsibilities

Medical Writing & Clinical Trial Transparency

Quality Control & Compliance

Collaboration & Client Communication

Training & Mentorship

Qualifications & Skills

Why Join Syneos Health?

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