Senior Regulatory Medical Writer, Client-embedded, FSP

Tasks

• Author IBs
• Author INDs
• Author MAAs
• Author clinical study protocols
• Author clinical study reports
• Author complex clinical and scientific documents
• Collaborate with cross-functional teams
• Ensure document accuracy and completeness
• Ensure regulatory guideline compliance
• Manage project timelines and deliverables
• Mentor junior medical writers
• Provide document content input
• Provide document presentation input
• Provide document structure input
• Review and provide feedback
• Summarize clinical study data
• Track regulatory guideline updates

Perks/Benefits

• 401k retirement plan
• Commuter benefits
• Employee assistance programs
• Life insurance
• Long-term disability
• Medical/Dental/Vision insurance
• Paid Holidays
• Paid time off
• Parental leave
• Remote work
• Short-term disability
• Stock purchase plan
• Tuition reimbursement

Skills/Tech-stack

Clinical Research | Clinical study | Clinical study protocol | Clinical study report | Data Interpretation | Document Management | Excel | Grammatical Editing | Medical writing | Outlook | Project Management | Proofreading | Regulatory writing | Study Protocol