Project Manager, REMS Team

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the Project Lead and main contact for the sponsor.

• Responsible for the overall success of the project, encompassing quality, timelines, and budget.

• Set and communicate customer expectations to the project team effectively.

• Guide cross-functional project teams to achieve or surpass deliverables.

• Function as the primary liaison between the sponsor and the organization at the project level.

• Ensure adherence to internal and external escalation processes.

• Outline roles and communication paths for secondary project leads and vendor or delivery-subset leads as necessary.

• Exhibit financial stewardship through understanding contracts, aligning resources to budget, managing out-of-scope activities, negotiating changes, and executing timelines.

• Facilitate risk identification and issue resolution at the project level using RBQM/RESOLVE methodologies.

• Guarantee that the project team complies with organizational policies, SOPs, ICH-GCP, regulatory, and project-specific requirements.

⛳️ Requirements

• A minimum of 3-5+ years of proven experience in REMS (Risk Evaluation Mitigation Strategy) Project Management within a CRO/Pharma/Biotech setting.

• Bachelor's degree or equivalent relevant formal academic/vocational qualification.

• Prior experience equivalent to 8+ years.

• Proficient in technical and systems applications, including Microsoft Outlook, Word, Excel, PowerPoint, CTMS, Preclarus, and Clarity.

• Capable of delegating and prioritizing project team tasks in a dynamic environment.

• Strong oral and written communication, along with presentation skills.

• Proactive, solution-focused, and adept at adapting to shifting priorities and circumstances.

• In-depth knowledge of therapeutic areas and clinical development guidelines and regulations.

• Solid grasp of project management principles, including time, quality, cost, and financial understanding.

• Excellent interpersonal and customer service skills, including leading, motivating, and coordinating cross-functional project teams.

• Strong judgment, decision-making, critical thinking, and strategic analytical skills.

• Ability to negotiate, persuade, and influence others, with awareness of cross-cultural nuances.

• Capability to ensure adherence to organizational policies, SOPs, ICH-GCP, regulatory, and project-specific requirements.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A global team environment.

• Chance to contribute to scientific excellence and innovation.