​This is a full-time, Remote (US) role within UBC’s Safety and Risk Management Department. This position is a specialized blend of high-level project management, financial oversight, and scientific contribution within the pharmaceutical support industry. You will be responsible for the operational success of risk management projects, epidemiologic studies, and registries that enhance the drug development and commercialization lifecycle.

• ​Requisition ID: 6954
• ​Experience Required: Senior-level experience in pharmaceutical, biotech, or CRO environments.
• ​Core Focus: Project management, scientific writing, and business development for safety and risk programs.
• ​Key Frameworks: REMS, EU RMPs, RiskMAPs, and GVP (Good Pharmacovigilance Practices).

​Key Responsibilities: Operations, Science, and Business

​The Senior Project Manager at UBC operates at the intersection of clinical research and regulatory compliance, ensuring that safety-related deliverables are met with precision.

​Project Management & Finance

​You will have direct responsibility for tracking and managing timelines for SERRM projects. This includes quantifying timeliness by tracking planned vs. actual delivery dates, monitoring resource utilization (hours), and collaborating with Finance and Contracts to manage budgets and invoicing based on project milestones.

​Scientific and Regulatory Contribution

​Beyond managing schedules, you will lead the operations for epidemiologic studies and registries. You will participate in the preparation and design of:

• ​RiskMAPs and REMS: Developing Risk Evaluation and Mitigation Strategies for the US market.
• ​EU RMPs: Preparing Risk Management Plans for the European market.
• ​Scientific Documents: Designing protocols, abstracts, manuscripts, and educational materials.
• ​Literature Research: Retrieving and analyzing epidemiology and non-clinical data from PSURs (Periodic Safety Update Reports) and DUS (Drug Utilization Studies).

​Business Development & Process Improvement

​You will act as a bridge between the technical team and the sales organization by supporting the development of service descriptions and budgets for new proposals. Internally, you will drive process improvements and the maintenance of Standard Operating Procedures (SOPs) to ensure the department remains compliant and efficient.

​Desired Skills and Qualifications

​UBC is looking for a detail-oriented leader who can navigate the complexities of scientific terminology and regulatory documentation.

• ​Education: Bachelor’s degree (Scientific or Pharmaceutical degree preferred).
• ​Industry Context: Proven experience within a Clinical Research Organization (CRO) or biotech environment.
• ​Technical Writing: Familiarity with protocol writing and study design; proficiency with medical and scientific terminology is essential.
• ​Project Tools: Advanced knowledge of project management techniques and computer proficiency (specifically for managing complex tables and figures).
• ​Soft Skills: High degree of accuracy, self-motivation, and the ability to thrive in a fast-paced environment where learning different research areas is required.