Director, Global Medical Writing - Remote

Overview

This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science that continuously evolves with new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.

In Short

• Hands-on role focused on writing responsibilities, including acting as the Lead Medical Writer for complex studies/documents.
• Mentor junior medical writers as needed.
• Overall responsibility for planning, implementing, and adhering to medical writing timelines.
• Represent Medical Writing on cross-functional teams and participate in submission planning.
• Strong team player and change agent who enhances the company’s cultural values.
• Excellent collaboration and people management skills.
• Lead/participate in significant workstreams across departments and with external vendors.
• Develop and participate in department training and SOP development.
• Perform reviews of medical writing deliverables and statistical analysis plans.
• Maintain cutting edge knowledge of current developments in the field.

Requirements

• PhD or equivalent plus 8+ years of experience, or Masters/Bachelors plus 12+ years of experience.
• Extensive experience authoring regulatory and clinical documents for global submissions.
• Excellent verbal and written communication skills and attention to detail.
• Experience producing high quality clinical documents.
• Knowledge of clinical trial disclosure.
• Strong organizational/prioritization skills.
• Proficiency with eCTD templates and MS Office software.
• Oncology, immunology, and/or neurology experience preferred.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.