Senior Director, Medical Writing

Perspective Therapeutics

Senior Director of Medical Writing providing strategic leadership in regulatory documents for oncology. Overseeing medical writing function and managing a team while ensuring compliance.

Posted 4/21/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide strategic leadership and oversight of the medical writing function.
Own the end-to-end medical writing function, including planning, resourcing, execution, and delivery of documents.
Lead the development of complex regulatory documents as programs advance.
Ensure all written materials meet regulatory requirements and support inspections.
Establish best practices and document standards.
Partner closely with clinical development, regulatory affairs, and other stakeholders to ensure integration of medical writing.
Lead and mentor a team of medical writers, fostering technical excellence and accountability.

Requirements

What you’ll need

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 across development stages.
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 (e.g., CoAuthor or similar platforms) 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.
Strong organizational and project management skills, with the ability to manage multiple priorities.
Adaptability to a dynamic, growth-stage company environment.

Benefits

Comp & perks

Health insurance
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingregulatory submissionsoncologydocument management systemsICH-GCPstrategic leadershipproject managementcomplex regulatory documentsregulatory interactionsattention to detail

Soft Skills

leadershipmentoringstrategic thinkingcommunicationorganizational skillsadaptabilityexecution capabilitiesteam managementaccountabilityfostering technical excellence

Certifications

PhD in Life SciencesPhD in Medicine