Principal Medical Writer
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Lead
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
medical writingscientific writingclinical documentspreclinical documentsregulatory documentsdata interpretationproject managementbest practices developmentcompliancedocument development guidelines
Soft skills
interpersonal skillsproblem solvingnegotiation skillsoral communicationwritten communicationpresentation skillsmentorshipcollaborationoperational excellencetraining
Certifications
AMWAEMWARAC