Scientific Writer II

About the role

Coordinate and author regulatory documents [eg, Investigator's Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.

What you'll do

• Coordinate and author regulatory documents [eg, Investigator's Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports
• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects
• Maintain document prototypes and shells
• Review and edit documents as required

What you need

• Writing
• Prototyping
• M.Pharm or PhD