CSL is seeking a Senior Director, Head of Medical Writing, who will be responsible for leading a team of medical writers to deliver high-quality clinical development documents. The role involves collaboration with CRO partners and internal teams to ensure effective communication and compliance with regulatory requirements
Job Summary
The incumbent will be responsible for the quality and delivery of high-quality clinical development documents across the portfolio in collaboration with strategic CRO partners.
Responsible for overseeing the recruiting, staffing and training development of the medical writing specialists in the group.
Develop a strategy for incorporating technologies to enhance and improve delivery of medical writing content (eg, AI tools).
Matching Summary
Match Score: 85
CSL is seeking a Senior Director, Head of Medical Writing, who will be responsible for leading a team of medical writers to deliver high-quality clinical development documents. The role involves collaboration with CRO partners and internal teams to ensure effective communication and compliance with regulatory requirements.
Skills & Requirements
Must-have
Clinical development documents
Strategic CRO partners
Recruiting, staffing, training
High-quality clinical content
Regulatory requirements
Messaging strategy across program
Quality Controls for documents
Nice-to-have
Agile team commitment
Dynamic biotech ecosystems
Culture of urgency, quality, innovation
Patient and health-care provider voice
Scientific integration with community
Key Requirements
Graduate level degree (M.Sc, PhD, MD etc)
10+ years of Pharma experience
Experience across all phases of development
Successful medical writing leadership track record
Experience across wide range of regulatory documents