Location
- United States
Category
The role
You'll lead medical writing deliverables for clinical studies, producing documents such as protocols, clinical study reports, patient narratives, and regulatory submissions while ensuring compliance with ICH E3 guidelines and client standards. You'll coordinate with data management, biostatistics, regulatory affairs, and medical affairs teams, mentor less experienced writers, and manage document reviews and budgets. This is a senior-level full-time remote position with minimal travel (less than 25%).
At a glance
- Level
- Senior
Tools and skills
Skills
AdaptabilityPlain Language SummariesScientific PresentationsProblem SolvingPresentationContent CreationCopyright ClearanceBiostatisticsStatistical Analysis PlansJournal ManuscriptsMedical WritingBudget ManagementDecision makingRelationship BuildingAbstract WritingPeer ReviewRegulatory AffairsInvestigator BrochuresInformed ConsentsQuality ReviewMedical AffairsData ManagementTime ManagementIND SubmissionsClinical Study ReportsDocument ManagementNDA SubmissionseCTD SubmissionsClinical Study ProtocolsICH E3 GuidelinesIntegrated Summary ReportsPatient NarrativesRegulatory StandardsMentoringClinical Literature SearchesOrganizationInitiativeLeadershipCommunicationCollaborationAttention to DetailClinical Development PlansPostersPeriodic Safety Update ReportsEditorial Review