Director, Medical Writing

Summary

As Director, Medical Writing, you will play a critical role in advancing Triveni Bio's clinical-stage portfolio by contributing to a broad range of clinical, regulatory, and scientific writing activities across multiple development programs. Reporting to the VP, Development Operations, you will serve as a key cross-functional partner to Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Clinical Pharmacology, and Translational Sciences teams to ensure the delivery of high-quality, scientifically accurate, and regulatory-compliant documents.

As Triveni's first medical writer, this is a unique opportunity for an experienced medical writer seeking broad exposure across the drug development lifecycle. You will support programs from early-stage regulatory submissions, including IND-enabling and IND documentation, through later-stage clinical development activities. On a day-to-day basis, you will develop and manage key clinical and regulatory documents, coordinate review cycles across internal stakeholders and external vendors, ensure consistency of messaging across development programs, and establish efficient medical writing processes as the organization continues to grow.

Responsibilities

• Lead the planning, authoring, review, and finalization of clinical and regulatory documents across Triveni's development programs.
• Develop clinical study protocols, protocol amendments, clinical study reports (CSRs), and related clinical development documentation.
• Author and/or coordinate key regulatory submission documents, including IND modules, Investigator's Brochures, briefing documents, annual reports, and responses to health authority requests.
• Partner with cross-functional subject matter experts to ensure scientific accuracy, completeness, and consistency across all deliverables.
• Manage document review workflows, version control, timelines, and stakeholder feedback to support program objectives and regulatory submission deadlines.
• Ensure documents comply with applicable regulatory requirements, ICH guidelines, company standards, and industry best practices.
• Lead the development and maintenance of medical writing templates and style guides, and support the development of relevant SOPs.
• Collaborate with external vendors, and oversee contract medical writers as needed.
• Provide medical writing expertise and guidance to cross-functional teams throughout the development lifecycle.
• Other duties as assigned.

Experience & Qualifications

• Advanced degree (PhD, PharmD, MD, MS, or equivalent) in a life sciences, biomedical, or healthcare-related discipline.
• 8+ years of medical writing experience within the biotechnology, pharmaceutical, CRO, or related life sciences industry.
• Demonstrated experience authoring and managing regulatory and clinical development documents, including protocols, CSRs, Investigator's Brochures, and IND-related submissions.
• Strong understanding of ICH guidelines, GCP requirements, and global regulatory documentation standards.
• Experience supporting multiple clinical development programs and collaborating effectively within cross-functional drug development teams.
• Experience developing scientific publications, congress materials, or other Medical Communications deliverables is a plus.