Senior Medical Writer – Client Aligned

Role Overview

• Write and edit clinical and regulatory documents
• Collaborate with cross-functional teams
• Ensure documents align with regulatory guidelines and industry best practices
• Review documents prepared by team members
• Manage timelines and deliverables for projects
• Mentor junior medical writers

Requirements

• Bachelor's degree in a scientific discipline or equivalent
• Regulatory writing experience comparable to 5+ years
• Experience in the pharmaceutical/CRO industry
• Experience in managing complex medical writing projects
• EU CTR experience preferred
• Excellent organizational and program management skills.
• Proven leadership skills to manage and mentor a team of medical writers.
• Extensive knowledge of regulatory guidelines and drug development processes.
• Strong interpersonal and communication skills.
• Understanding of quality control processes.

Benefits

• Professional development opportunities