Senior Manager, Medical Writing - Remote

Overview

The Senior Manager, Medical Writing will be responsible for document development and managing medical writing activities and timelines for clinical and regulatory/health authority drug marketing applications.

In Short

• Responsible for document development for drug marketing applications.
• Manage medical writing activities and timelines.
• Experience in submitting successful drug marketing applications required.
• Strong project management and scientific writing skills needed.
• Collaborate with cross-functional teams.
• Lead project-level writing teams with minimal supervision.
• Represent Medical Writing on cross-functional teams.
• Work independently in a fast-paced environment.
• Advanced degree in a relevant scientific field preferred.
• 7+ years of experience in regulatory/development medical writing.

Requirements

• Advanced degree in a relevant scientific field preferred; Bachelor of Science required.
• 7+ years of experience in regulatory/development medical writing.
• Experience with drug application submissions to US and ex-US health authorities.
• Extremely strong project management skills.
• Strong knowledge of biologics drug development and clinical research.
• Ability to work independently and creatively.
• Common sense.

Benefits

• Opportunity to work in a leading biopharmaceutical company.
• Engage in innovative therapeutic approaches.
• Collaborate with cross-functional teams.
• Work in a fast-paced environment.
• Contribute to life-changing therapies.