Program Specialist

Premier Research

19d

About The Position

Premier Research is looking for a Program Specialist to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Requirements

• Bachelor’s degree, or international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field, or equivalent combination of education, training and experience
• Minimum of 3 years' experience in pharmaceutical or biotechnology drug development, including exposure to project/program management
• Demonstrates excellent English verbal and written communication skills

Nice To Haves

• Late-stage development experience preferred
• Experience with clinical development phases and proficiency in project management software and tools (e.g. Smartsheet, SharePoint or similar)

Responsibilities

• Partners with the Program Management team to facilitate timely planning, execution, tracking, and completion of NDA-related clinical deliverables through coordination and oversight of the cross-functional project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety)
• Collects and analyzes data from functional leads to ensure timelines and data collection meet all applicable regulations, standards, and study-specific requirement
• Provides project coordination; sets up meetings, drafts agendas, creates detailed minutes, and tracks actions through completion
• Assists in customizing project templates and developing and maintaining tracking tools for project documents/deliverables and monthly progress reports
• Ensures effective and timely communication to cross-functional project team regarding activity status, key milestones, identified risks and resource allocation

Benefits

• comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees