Medical Writer

Job Summary

A company is looking for a Medical Writer (Contract) to provide expertise in authoring medical writing deliverables and ensure compliance for clinical programs.

Key Responsibilities:

• Lead teams in delivering high-quality medical writing documents in accordance with regulations and internal requirements
• Ensure clear accountability and communication across functions for multidisciplinary documents submitted to regulatory agencies
• Establish and standardize medical writing practices and systems to improve efficiency and quality

Required Qualifications:

• Master's Degree in a scientific discipline, with a preference for a Doctorate degree
• At least 12 years of experience in medical/regulatory writing operations, including 4 years of team leadership
• Strong background in medical writing operations, including staff management
• Experience with ICH, eCTD, and submission requirements for clinical/research reports
• Ability to understand and utilize new technology and systems in medical writing