Senior Director, Medical Writing Portfolio Management - Remote

Overview

The Senior Director, Medical Writing Portfolio Management, coordinates and facilitates Medical Writing portfolio needs to support all phases of producing high quality, specialty submission documentation that comply with internal and external standards.

In Short

• Lead Medical Writing portfolio management for regulatory submissions.
• Collaborate with Project Management for document delivery.
• Manage submission documents and resolve issues.
• Ensure compliance with regulations and guidelines.
• Supervise and develop the Medical Writing Department.
• Establish timelines and manage cross-functional relationships.
• Oversee budgets for medical writing resources.
• Develop and manage department SOPs and templates.
• Communicate effectively across all levels of the organization.
• Adapt to a fast-paced biotech environment.

Requirements

• B.S./B.A. degree required.
• 10+ years of medical writing experience.
• 5+ years in a managerial role.
• Detail-oriented mindset for quality control.
• Experience in clinical operations (2-4 years).
• Strong organizational skills and ability to manage multiple projects.
• Excellent communication skills.
• Proficient in MS Office and electronic review tools.
• Ability to lead cross-functional teams.
• Self-motivated with strong initiative.

Benefits

• Competitive salary range of $260,000 - $280,000/year.
• Unlimited paid time off.
• Parental leave policy.
• Comprehensive medical, dental, and vision benefits.
• 401k plan with company match.
• Equity and other forms of compensation available.