Medical Research & Operations Manager
Core
Lead and manage all Non-Interventional Studies (NIS) operations, including regulatory PMSS, Access Programs, and multi-country studies, ensuring compliance with corporate, ethical, and legal requirements.
Role type
Senior Medical Research & Operations Manager
Builds
Non-Interventional Studies (NIS) deliverables, study protocols, and regulatory dossiers for new assets/indications
Domain
Clinical research / Regulatory affairs / Pharmaceutical industry
Deliverable
client delivery
Required skills
Non-Interventional Studies (NIS) management, regulatory compliance (ICH guidelines), project management (schedule, budget, resources), people management and leadership, study budget planning and tracking, quality and compliance monitoring, strategic planning for new study types (Post Trial Access, IP supply IIS)
Preferred skills
Clinical research experience, financial management, cross-functional collaboration
Technologies
None stated
Responsibilities
Lead team members and activities of all Non-Interventional Studies (NIS); manage medical research operations and represent NIS on cross-functional projects; plan, coordinate, oversee, and conduct all NIS activities; line management and mentoring of the medical research & operation team; manage workload, plans, and resource needs; conduct quality and compliance monitoring; lead and provide guidance on newly conducted types of studies; plan and prepare study concept/protocol for NDA dossiers; provide regulatory requirements and budget estimates to cross-functional teams; estimate study completion and subject enrollment; develop strategy for re-examination period submissions; lead preparation of reference documents for MFDS submission
Seniority
Senior, hands-on IC with people management