About the Context

Are you an experienced Project Manager in life sciences, passionate about driving change in clinical trial execution? We are hiring a Regulatory, Quality & Safety (RQS) Project Manager to support a major transformation initiative focused on reimagining clinical trial operations across global R&D. In this role, you will work cross-functionally with senior stakeholders in Regulatory Affairs, Quality, and Clinical Operations to drive alignment, deliver workstream milestones, and shape scalable processes. This is a high-impact role ideal for individuals with strong program leadership experience, combined with expertise in regulated environments (GCP, regulatory, or clinical).

About the Role

-Lead and coordinate RQS contributions across 5 strategic workstreams:

• Operating Model
• Transactional Systems
• Capability Building
• Resource & Capacity Planning
• Vendor/FSP Management

-Define and execute a comprehensive project plan with clear deliverables, timelines, and risk mitigation strategies.

-Act as the central point of alignment across Regulatory, Quality, and Safety functions—bridging internal silos and ensuring consistency.

-Facilitate workstream meetings, track milestones, manage documentation, and drive cross-team communication.

-Identify, manage, and escalate project risks or misalignments to senior leadership and governance boards.

-Connect dots across technical, operational, and change management topics, ensuring that clinical systems and processes are interconnected and future-ready.

-Summarize status updates, drive cross-functional engagement, and coordinate backfill and resourcing needs.

Must Qualifications

• Minimum 6–8 years of project or program management in the pharmaceutical or biotech industry
• Experience in R&D environments: regulatory, clinical development, or quality
• Strong track record in cross-functional coordination and managing stakeholder expectations
• Familiarity with clinical trial processes, GCP principles, or regulated systems
• Proven ability to work in global matrix organizations
• Excellent communication, facilitation, and documentation skills
• Agile mindset
• Fluency in English (written and spoken)

Nice-to-Haves

• Hands-on experience in clinical trial operations, regulatory project delivery, or quality system implementation
• Experience working with FSP/CRO models or clinical trial vendors
• Familiarity with digital systems transformation or capability building programs

Job Types: 100%, Fixed term
Contract length: 6 months

Work Location: Remote

Expected Start Date: 01/05/2025