Senior Medical Writer – Client Aligned
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Job Description
Senior Medical Writer responsible for developing clinical and regulatory documents for Thermo Fisher Scientific. Collaborating with teams to ensure accuracy and compliance with regulatory guidelines.
Responsibilities:
- 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
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