Location
- United States
The role
You'll lead and write clinical and regulatory documents for drug and device development, working with subject matter experts and cross-functional teams to ensure quality and compliance. This senior role offers moderate autonomy, involves coordinating reviews and inspections, and requires a minimum of 4+ years in the bio-pharmaceutical industry. The position is full-time and based in a hybrid work environment.
At a glance
- Education
- Bachelor's Degree
- Experience
- 4+ years
- Level
- Senior
Tools and skills
Skills
Regulatory DocumentationScientific TerminologyPRISMA GuidelinesProblem SolvingRegulatory WritingContent CreationBiostatisticsClinical ResearchClinical DocumentationCONSORT GuidelinesAutonomyMedical WritingData AnalysisProcess ImprovementRegulatory ComplianceICH GuidelinesTime ManagementMedical TerminologyStudy DesignPharmacologyOrganizationQuality ControlProject ManagementLeadershipCommunicationCollaborationAttention to DetailDrug Development