Associate Scientific Regulatory Writing Director

Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development.

Requirements

• Independently leads content development for regulatory and clinical documents
• Incorporates diverse reviewer feedback
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources
• Assigns and supervises partner regulatory editors
• Proposes and manages timelines for the document development process
• Oversees the assembly of appendices for regulatory submission documents
• Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams
• Provides writing guidance to internal teams
• Peer reviews project work and training materials/guidelines
• Contributes to SOP and work instruction development and review
• Manages the execution of multiple tasks
• Ensures appropriate prioritization and execution
• Proactively anticipates, prioritizes and resolves task-related challenges

Benefits

• Comprehensive employee benefits package
• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Long-term incentives
• Accrued vacation days
• Paid holidays
• Sick days