Lead Medical Writer

Job Description

We are seeking a highly experienced Senior Medical Writer to join our team and contribute significantly to our growing workload. This role involves writing specific clinical and regulatory documents while managing the process efficiently, ensuring successful cross-functional collaboration.

Responsibilities

• Create and manage clinical and regulatory documents, including Protocols & Amendments, Clinical Study Reports (CSRs), Investigator Brochures, and Meeting Briefs.
• Work collaboratively across functions to gather necessary information for document creation.
• Contribute to both clinical and regulatory writing processes, ensuring accuracy and compliance.

Essential Skills

• 10+ years of medical writing experience.
• Experience with clinical and regulatory documents.
• Experience working with a sponsor, preferably in small pharma.
• Bachelor's degree in a relevant field.
• Experience in rare diseases is preferred.
• Experience with global submissions is advantageous.

Additional Skills & Qualifications

• Biotech or Pharma experience, especially in small biotech or pharma environments.
• Project management skills.

Work Environment

This is a 100% remote role, offering a long-term, consistent consulting opportunity. Work closely with the Head of Medical Writing in a fast-paced, collaborative environment. Although work hours vary between 30-40 hours per week, flexibility is required.