Senior Medical Writer – Client Aligned

This is a fully remote position, open to applicants in Romania.

📋 Description

• Develop and revise clinical and regulatory documentation

• Work collaboratively with cross-functional teams

• Ensure that documents meet regulatory standards and industry best practices

• Assess and provide feedback on documents created by team members

• Oversee timelines and deliverables for various projects

• Provide mentorship to junior medical writers

⛳️ Requirements

• A Bachelor's degree in a scientific field or an equivalent qualification

• At least 5 years of experience in regulatory writing

• Background in the pharmaceutical or CRO industry

• Proven ability to manage complex medical writing projects

• Experience with EU CTR is preferred

• Exceptional organizational and program management capabilities

• Demonstrated leadership skills for managing and mentoring a team of medical writers

• Comprehensive understanding of regulatory guidelines and drug development processes

• Strong interpersonal and communication abilities

• Familiarity with quality control procedures

🏝️ Benefits

• Opportunities for professional growth and development