Rens van den Boomen
Associate Director
Rens has over 20 years of experience in pharma and biotech and houses extensive knowledge across multiple domains: IT, Regulatory, Shared Services, Pharmacovigilance, Quality, Medical Affairs, Commercial, Manufacturing and Supply Chain. His sweet spot is working in complex environments where information, systems, people, and processes meet.
Expertise
- IT, RA, QA & PV systems and processes
- Project, Program and (IT) Portfolio Management
- Business analysis, transformations and (organizational-) re-design
- Data Governance & Data Management
- System/technology selection, implementation, validation & migration
- System Development & Lifecycle Management
- US and EU regulations on (human) medicines and medical devices
Project Experience
- Senior Director IT in a mid-sized biotech company accountable for the IT strategy and associated budget & full project portfolio
- Managing Consultant involved in multiple, system selections implementations, validations & migrations for RIMS, QMS, DMS, Safety Databases, Medical Information Management, ITSM, CMDB and others
- Team member involved in multiple business transformations, process optimalizations and organizational re-designs
- Subject Matter Expert on (new) regulations, including data standardizations and submission requirements (E.g. XEVMPD, IDMP, PSMF, PSURs, ICSRs, Device Vigilance). CAPAs, NCs & Deviations. And as mitigation to (FDA) warning letters
- Technical writer for procedures (E.g. SOPs, WIs). Development and execution of system and procedural based training for system owners, business process owners & others
- Line manager accountable for delivery, personal development and wellbeing of project managers, business analysts, cyber security experts, IT architects, vendor managers, compliance managers & business improvement managers