- Monitors projects within the business unit to assure PRA profitability, associated project goals and objectives of high quality deliverables are met.
- Maintains familiarity with current industry practices and regulatory requirements that affect benefit/risk evaluations, NDAs/BLAs/MAAs, and changes to labeling and marketing authorizations.
- Substantial experience in the pharmaceutical industry with significant experience in a leadership position in safety and risk management in industry-related clinical research.
- Demonstrated experience in a line management role.
- Proven history of successful involvement driving a strategic, global, cross-functional initiative.
- History of successful in interactions with regulatory authorities, IRBs/Ethics Committees, medical community, knowledge of regulatory requirements for human drugs, biologics, and/or devices.
- Proven history of leadership of business development initiatives.
- Experience in preparing, implementing, and managing departmental operating plans.
- Experience in process re- engineering.
- An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences.
- Postgraduate degree in epidemiology, statistics or public health or equivalent degree, preferred.
- Excellent written and oral communication and presentation skills.
- Reads, writes, and speaks English; fluent in host country language required.
LOCATION: This position can be located in the United States, Canada, Germany, the UK or another EU country. Options are available for a home-based or an office-based position in the locations noted.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.