Principal Medical Writer
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
About the role
- Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts
- Collaborate with internal and external clients
- Support and enable effective and efficient communication resulting in operational excellence
- Author clinical and preclinical regulatory documents with expertise in infectious diseases and/or oncology
- Serve as a primary author for clinical documents
- Review routine documents prepared by team members
- May provide training and mentorship for writers
- Ensure compliance with quality processes and requirements
- Develop best practices, methods, and techniques for achieving optimal results
Requirements
- Bachelor's degree in a scientific field or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- Excellent data interpretation and medical writing skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national, and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical or regulatory submissions
Benefits
- award-winning learning and development program
- competitive salary
- extensive benefits package
- flexible working culture
- work-life balance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingscientific writingclinical documentspreclinical documentsregulatory documentsdata interpretationproject managementbest practices developmentcompliancedocument development guidelines
Soft Skills
interpersonal skillsproblem solvingnegotiation skillsoral communicationwritten communicationpresentation skillsmentorshipcollaborationoperational excellencetraining
Certifications
AMWAEMWARAC