Senior Director, Medical Writing

🕒 April 21

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Perspective Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2023

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $400k Grant on 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

Perspective Therapeutics is a biotechnology company focused on developing innovative cancer treatments through a unique class of theranostics. Their proprietary technologies enable the targeting of specific tumors for treatment while minimizing toxicity to healthy tissues. By utilizing radiation, radiopharmaceuticals, and advanced imaging technologies, they aim to improve treatment efficacy and provide better outcomes for cancer patients.

📋 Description

• 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

• 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

• Health insurance • Paid time off • Flexible work arrangements • Professional development opportunities