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Biotech
Prepare, author, and review pharmacovigilance and safety documents (PSURs, DSURs, RMPs, narratives, signal reports). Lead report management, client communication, literature searches, quality review of junior writers, and ensure regulatory compliance and timely delivery of high-quality safety deliverables.
Biotech
Lead and track quality issues within the QMS, support CAPA creation, pull metrics and trend quality indicators, communicate quality summaries internally and to clients, and assist QA leadership as needed.
Biotech
The Senior Director of Strategic Accounts leads complex sales initiatives, develops growth strategies, builds client relationships, and achieves revenue targets within key accounts.
Biotech
Perform and own quality reviews and metrics for pharmacovigilance and safety-writing projects; draft CAPAs and quality management plan sections; review adverse event cases, complaints, and regulatory documents; support audits and inspections; train and guide associates; analyze data to drive process improvements and ensure compliance with regulatory and QA standards.
Biotech
Lead product strategy and development for data management solutions in life sciences, ensuring market relevance and user satisfaction while managing lifecycle and stakeholder alignment.
Biotech
Manage and oversee regulatory authority, IRB/EC, and Third Body submissions for clinical site readiness. Plan submission strategy and timelines, ensure compliance with regulations, support CTIS/EU CTR activities, coordinate with local teams, track milestones, support audits, mentor junior staff, and contribute to process improvements and project financial management.
