Senior Medical Writer – Early Development Services
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Netherlands
Visit company websiteExplore more
Job Level
About the role
- Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies
- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
- Ensure compliance with quality processes and requirements for assigned documents
- May assist in determining best practices, methods and techniques for achieving optimal results
- May assist in program management activities, including developing timelines, budgets, forecasts for assigned deliverables
- Represent the department at project launch meetings, review meetings, and project team meetings
Requirements
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required
- Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 5+ years)
- Experience working in the pharmaceutical/CRO industry required
- Experience in managing and directing complex medical writing projects required
- Early phase experience is 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 to build and maintain effective working relationships with colleagues and stakeholders
- Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
- Self-motivated and adaptable
- Excellent judgment; high degree of independence in decision making and problem solving.
Benefits
- Competitive salary
- Award-winning learning and development programme
- Flexible working culture
- Health and well-being benefits
- Collaborative environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory writingclinical study reportsstudy protocolsIBsINDsMAAsprogram managementquality controldrug development processesmedical writing
Soft Skills
organizational skillsprogram management skillsleadership skillsmentoringinterpersonal skillscommunication skillsdecision makingproblem solvingself-motivatedadaptability
Certifications
Bachelor's degree in a scientific discipline