Senior Medical Writer

Accountabilities:

• Independently lead the preparation, review, and delivery of clinical trial transparency and disclosure submissions across multiple jurisdictions.

• Develop and review protocol registrations, results postings, plain language summaries (PLS), lay protocol synopses (LPS), redaction and anonymization packages, anonymization reports, and CCI justification tables.

• Apply advanced medical writing expertise to 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 to clients and internal teams on clinical trial disclosure and transparency requirements.

• Lead client interactions and provide consultation on complex disclosure and regulatory matters.

• Manage complex disclosure projects independently from initiation through final delivery, ensuring timelines, quality expectations, and regulatory requirements are met.

• Interpret applicable regulations and provide practical, strategic recommendations that support informed client decision-making.

• Ensure submissions and disclosure materials comply with applicable requirements across multiple global jurisdictions.

• Contribute to process improvement initiatives, best-practice development, and the continuous enhancement of disclosure workflows.

• Mentor and train junior team members on disclosure requirements, document preparation, regulatory compliance, and quality standards.

Requirements:

• Demonstrated professional experience in medical writing, with significant specialized expertise in clinical trial disclosure and transparency.

• Thorough knowledge of global clinical trial disclosure requirements and platforms, including ClinicalTrials.gov, EudraCT, EU-CTR/CTIS, EMA Policy 0070, and Health Canada requirements.

• Extensive experience with protocol registration, results reporting, registry maintenance, and clinical trial disclosure compliance strategies.

• Strong understanding of health literacy principles and proven ability to develop clear, accessible, patient-facing disclosure documents.

• Thorough knowledge of data protection requirements and their practical application to anonymization and redaction activities.

• Advanced expertise in identifying, assessing, and justifying personally identifiable data (PPD) and confidential commercial information (CCI) redactions.

• Strong understanding of clinical and regulatory documentation, with advanced writing and review capabilities.

• Excellent written and verbal English communication skills, with the ability to explain complex scientific and regulatory concepts clearly.

• Strong client-facing and stakeholder management skills, including the ability to provide confident regulatory guidance.

• Excellent attention to detail, organization, and ability to manage multiple complex projects independently.

• Bachelor’s degree in life sciences, health sciences, or a related field, or equivalent professional experience.

• Ability to mentor colleagues and contribute proactively to team knowledge, process improvement, and best-practice development.

Benefits:

• Full-time remote position based in Bengaluru, India.

• Opportunity to work on global clinical research and clinical trial transparency projects.

• Exposure to complex regulatory requirements across multiple international jurisdictions.

• Opportunity to collaborate with global clients and multidisciplinary clinical research teams.

• Professional development through mentoring, regulatory expertise, and involvement in process improvement initiatives.

• Meaningful opportunity to contribute to greater clinical research transparency and patient access to trial information.

• Opportunity to work within a global clinical research environment focused on advancing healthcare and life-changing therapies.