Senior Medical Writer

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee the preparation, assessment, and submission of clinical trial transparency documents, including protocol registrations, results postings, plain language summaries, lay protocol synopses, redaction/anonymization packages, anonymization reports, and CCI justification tables.

• Write and evaluate clinical and regulatory documentation, encompassing Study Protocols, Clinical Study Reports, Investigator Brochures, Informed Consent Forms, Clinical Overviews, Clinical Summaries, and Safety Reports.

• Offer strategic and regulatory advice regarding clinical trial disclosure obligations to clients and internal teams.

• Manage client relationships and deliver consultation on intricate regulatory issues related to disclosure.

• Oversee intricate disclosure projects from their inception to completion.

• Provide regulatory insights and strategic advice to facilitate client decision-making processes.

• Contribute to enhancements and the establishment of best practices within the disclosure team.

• Mentor and instruct junior team members on disclosure obligations, document creation, and adherence to regulatory standards.

• Ensure that submissions adhere to quality benchmarks and regulatory standards across various jurisdictions.

⛳️ Requirements

• Proven experience in the medical writing sector, with a strong focus on clinical trial disclosure and transparency.

• Comprehensive knowledge of global regulations governing clinical trial disclosure and transparency, including ClinicalTrials.gov, EudraCT, EU-CTR/CTIS, EMA Policy 0070, and Health Canada mandates.

• Significant experience with protocol registration, results reporting, registry upkeep, and strategies for disclosure compliance.

• In-depth understanding of health literacy principles and a proven track record in creating clear, patient-oriented disclosure documents.

• Solid grasp of data protection laws and their implications for anonymization and redaction processes.

• Advanced proficiency in identifying and justifying PPD (Personally Identifiable Data) and CCI (Confidential Commercial Information) redactions.

• Exceptional written and verbal communication abilities, with a knack for clearly articulating complex regulatory concepts.

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

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.