Key Responsibilities

• Serve as a lead on complex clinical & regulatory documents.
• Work closely with the team(s) on document authoring & content strategies.
• Coordinate review, approval, & quality control of other functions involved in the production of clinical & regulatory projects.
• Communicate deliverables needed, writing process, & timelines to team members.
• Hold team members accountable to agreed-upon project dates.
• Work independently with Regulatory Quality Assurance to address inquiries & draft responses.