Clinical Documentation Specialist responsible for receiving and processing healthcare documentation requests. Analyzing and validating requests while ensuring compliance with regulations and organizational standards.
TS
Onsite Senior Medical Writer – Early Development Services
Posted 3 days ago
About the role
- Senior Medical Writer shaping key clinical and regulatory documents at Thermo Fisher Scientific. Collaborating with teams to drive strategy, quality, and execution of early-phase programs.
Responsibilities
- Serve as primary author for clinical study reports and protocols
- Summarize data from clinical studies
- Ensure compliance with quality processes and requirements for documents
- Assist in determining best practices and methods
- Assist in program management activities (timelines, budgets, forecasts)
- Represent the department at project launch and review meetings
Requirements
- Bachelor's degree in a scientific discipline or equivalent
- Advanced degree preferred
- Regulatory writing experience (comparable to 5+ years)
- Experience in pharmaceutical/CRO industry
- Experience in managing/writing complex medical documents
- Early phase experience is preferred
- Excellent organizational and program management skills
- Proven leadership skills to manage/mentor a team of medical writers
- Extensive knowledge of regulatory guidelines and drug development processes
- Understanding of quality control processes
Benefits
- Competitive salary
- Award-winning learning and development programme
- Flexible working culture
- Health and well-being benefits
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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