Senior Medical Writer – Early Development Services
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Netherlands
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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
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