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Senior Director, Medical Writing
Perspective Therapeutics. Provide strategic leadership and oversight of the medical writing function.
Tech Stack
Tools & technologiesGoogle 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
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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