[Hiring] Senior Director, Medical Writing @Perspective Therapeutics

Role Description

The Senior Director, Medical Writing provides strategic leadership and accountable oversight of the end-to-end medical writing function to deliver high-quality, inspection-ready regulatory and scientific documents across all stages of development. This role serves as the accountable medical writing lead for regulatory submissions and document strategy, providing oncology-focused expertise while driving quality, timelines, and review-cycle efficiency.

• Own the end-to-end medical writing function, including planning, resourcing, execution, and delivery of regulatory and scientific documents.
• Provide strategic input into development and regulatory strategy through authorship planning, document sequencing, and content alignment.
• Initially serve in a hands-on capacity by personally authoring and/or leading the drafting, review, and finalization of core regulatory and scientific documents.
• Serve as the accountable medical writing lead for regulatory submissions, ensuring consistency, completeness, and submission readiness.
• Act as the primary medical writing representative in cross-functional governance forums and program-level decision-making.
• Lead the development of complex, integrated regulatory documents, including INDs, NDAs, MAAs, and briefing documents.
• Provide senior-level leadership in the development of clinical trial protocols, clinical study reports, Investigator Brochures, and scientific publications.
• Ensure alignment with ICH, FDA, EMA, and other global regulatory standards.
• Establish best practices, templates, and document standards to enhance consistency, quality, and efficiency.
• Ensure all written materials meet regulatory requirements, company SOPs, and inspection-ready standards.
• Establish and monitor key performance indicators (KPIs) for medical writing quality, timelines, and review cycle efficiency.
• Lead continuous improvement initiatives to optimize medical writing processes and cross-functional collaboration.
• Lead the selection, onboarding, and oversight of external medical writing vendors.
• Manage internal and external resourcing strategies to meet program timelines and corporate milestones.
• Partner closely with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other stakeholders.
• Lead and mentor a team of medical writers, fostering technical excellence and professional development.
• Cultivate a culture of collaboration, innovation, and high performance within the medical writing function.
• Serve as a subject matter expert in oncology medical writing, maintaining current knowledge of scientific, clinical, and regulatory advancements.
• Represent the medical writing function in internal and external interactions.

Qualifications

• Advanced degree in Life Sciences, Medicine, or a related field; PhD preferred.
• Minimum of 12 years of medical writing experience, with significant focus on oncology and regulatory submissions.
• Demonstrated experience leading medical writing strategy and delivering complex regulatory documents.
• Proven experience supporting regulatory interactions and submissions (IND, NDA, MAA).
• Strong leadership experience with the ability to build, manage, and mentor high-performing teams.
• Experience with document management systems and tools preferred.
• Deep understanding of ICH-GCP and global regulatory requirements.
• Strong strategic thinking and execution capabilities in a fast-paced environment.
• Exceptional written and verbal communication skills with strong attention to detail.
• Ability to influence cross-functional stakeholders and senior leadership.
• Strong organizational and project management skills, with the ability to manage multiple priorities.
• Adaptability to a dynamic, growth-stage company environment.

Work Environment

• Work is primarily performed in a remote/home-office setting; prolonged periods of sitting and working at a computer may be required.
• Frequent collaboration via virtual meetings with cross-functional teams and external partners.
• Work is deadline-driven and may require managing multiple programs and priorities simultaneously.
• May require occasional travel (up to 10%) for key meetings, as business needs dictate.