Associate Director, Medical Writing (Clinical and Regulatory) - Remote

Overview

The Associate Director, Medical Writing will be responsible for writing and coordinating the writing of various clinical and regulatory documents, ensuring high quality and compliance with regulations.

In Short

• Responsible for writing clinical and regulatory documents.
• Work with cross-functional teams to manage document preparation.
• Ensure compliance with SOPs and regulatory guidelines.
• Lead medical writing initiatives across global teams.
• Participate in project teams as the writing representative.
• Implement clinical transparency in document development.
• Develop collaborative relationships with stakeholders.
• Ensure timely document management from start to finish.
• Distill complex data into essential elements for presentation.
• Maintain knowledge of relevant clinical and regulatory requirements.

Requirements

• BS, MS, or doctorate in a scientific or medical field.
• Six+ years in the biotechnology/pharmaceutical industry.
• Experience in medical writing and clinical development.
• Strong leadership and project management skills.
• Ability to work in a fast-paced environment.
• Exceptional communication skills.
• Proficient in Microsoft Office and Adobe Illustrator.
• Experience in rare disease or gene therapy is a plus.
• Willingness to travel occasionally.

Benefits

• Generous vacation time and public holidays.
• Volunteer days.
• Long-term incentive and stock purchase plans.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.