Clinical Documentation Specialist
Cleveland Clinic
Senior Principal Medical Writer – Regulatory, Oncology
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • Arizona, Maine, North Carolina, Ohio, Rhode Island • 🇺🇸 United States
Visit company websiteSalary
💰 $114,000 - $210,900 per year
Job Level
Senior
About the role
- Develop regulatory documents for submission to regulatory agencies globally
- Manage medical writing projects, including developing timelines and communication with cross-functional team members
- Participate in cross-functional meetings to provide input regarding medical writing deliverables
- Review other documents associated with the assigned project(s)
- Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents
- Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
- Mentor more junior medical writing staff
Requirements
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes
- Manage medical writing projects, including developing timelines and communication with cross-functional team members
- Participate in cross-functional meetings to provide input regarding medical writing deliverables
- Review other documents associated with the assigned project(s)
- Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents
- Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
- Mentor more junior medical writing staff
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory document developmentmedical writingproject managementtimeline developmentstandard operating proceduresquality document preparation
Soft skills
communicationcross-functional collaborationmentoring
