Senior Medical Writer

Overview

Serve as a Senior Medical Writer specializing in clinical trial disclosure and transparency. Lead clinical trial transparency submissions, provide regulatory guidance, manage complex disclosure projects, and mentor junior team members.

What you'll do

• Independently lead the preparation, review, and delivery of clinical trial transparency submissions, including protocol registrations, results postings, plain language summaries (PLS), lay protocol synopses (LPS), redaction/anonymization packages, anonymization reports, and CCI justification tables.
• Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
• Provide strategic and regulatory guidance on clinical trial disclosure requirements to clients and internal teams.
• Lead client interactions and provide disclosure-related consultation on complex regulatory matters.
• Independently manage complex disclosure projects from initiation through delivery.
• Provide regulatory interpretation and strategic recommendations to support client decision-making.
• Contribute to process improvements and best practice development within the disclosure team.
• Mentor and train junior team members on disclosure requirements, document development, and regulatory compliance.
• Ensure all submissions meet quality standards and regulatory requirements across multiple jurisdictions.

What you'll need

• Experience in the medical writing field with demonstrated expertise in clinical trial disclosure and transparency.
• Thorough understanding of global clinical trial disclosure and transparency regulations, including ClinicalTrials.gov, EudraCT, EU-CTR/CTIS, EMA Policy 0070, and Health Canada requirements.
• Extensive experience with protocol registration, results reporting, registry maintenance, and disclosure compliance strategies.
• Strong understanding of health literacy principles and demonstrated ability to develop clear, patient-facing disclosure documents.
• Thorough knowledge of data protection regulations and their application to anonymization and redaction activities.
• Advanced expertise in identifying and justifying PPD (Personally Identifiable Data) and CCI (Confidential Commercial Information) redactions.
• Excellent written and verbal communication skills with ability to explain complex regulatory concepts clearly.
• Bachelor's degree in life sciences, health sciences, or related field, or equivalent professional experience.

Details

• Location: Bengaluru, India.
• Remote work.