As the Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals
Job Summary
As the Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals.
Your role will involve developing communication strategies, optimizing document delivery, and supporting talent growth within our core therapeutic areas across all phases of clinical development.
Our inclusive environment fosters collaboration across global teams, unlocking regulatory knowledge to bring life-changing medicines to patients efficiently.
Matching Summary
As the Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals.
Salary
Competitive
Skills & Requirements
Must-have
Oncology drug development knowledge
Clinical interpretation skills
Stakeholder management skills
IND and NDA document authoring
Health authority responses
Program management experience
Nice-to-have
AI tools for medical writing
Team management experience
Bold thinking
Innovative approaches
Key Requirements
Master's degree in Scientific discipline
PhD strongly preferred
Proficiency in authoring/editing clinical regulatory documents
Experience managing writing/review of clinical regulatory documents