Principal Medical Writer – Submission Docs, Oncology
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • Arizona, Maine, Ohio, Rhode Island • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Develop regulatory documents for submission to regulatory agencies globally including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews.
- Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
Requirements
- eCTD submission experience preferred
- Develop regulatory documents for submission to regulatory agencies globally including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
- total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory documentsClinical Study ReportsClinical Summaries of Efficacy and SafetyClinical OverviewseCTD submissionmedical writingtimelines developmentProtocolsStatistical Analysis PlansICH guidelines
Soft skills
project managementcommunicationcross-functional collaborationinput provisionawareness maintenance