A pioneering force in AI-driven medical writing, one of the first to revolutionize the field, seeks a visionary Director of Medical Writing.

As Director of Medical Writing, you'll leverage a cutting-edge genAI platform to deliver exceptional documents, cultivate strategic client partnerships to fuel business expansion, and mentor a talented team of medical writers. Partnering with the Chief Scientific Officer, you'll champion regulatory compliance and uphold the highest industry standards.

Responsibilities:

• Forge and maintain strategic partnerships with CROs and biopharmaceutical companies to develop and review regulatory documents, including clinical study reports, investigator brochures, INDs, and other essential documents, ensuring submissions are on time and exceed client expectations
• Spearhead the creation and meticulous review of critical regulatory documents (CSRs, IBs, INDs, etc.), guaranteeing timely submissions that consistently surpass client standards
• Champion regulatory compliance by ensuring strict adherence to ICH, FDA, and EMA guidelines, while staying abreast of evolving industry trends
• Partner with cross-functional teams, including AI and automation specialists, to optimize our tools and workflows, disseminating valuable insights across the organization
• Contribute strategic expertise to refine medical writing processes and drive business expansion
• Synthesize key findings and actively participate in brainstorming sessions to leverage AI-driven insights in medical writing, while providing expert training and oversight

Requirements:

• 8+ years of experience in medical writing
• Masters or PhD in life sciences or any relevant field
• Experience working with contract or clinical research organizations
• Ability to lead a team

Pluses:

• AMWA Medical Writing certification
• Experience working with contract research organizations
• Understanding of industry regulations such as FDA, ICH and/or EMA
• Experience or exposure to artificial intelligence tools and/or services

This will be a critical hire for the company as much as an opportunity to be a trailblazer in the industry. Its 100% remote, full-time, direct hire, full suite of benefits, equity and 20% bonus eligibility.