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.
What you'll be doing:
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
What we are searching for:
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
Late-stage development experience preferred
Experience with clinical development phases and proficiency in project management software and tools (e.g. Smartsheet, SharePoint or similar)
Demonstrates excellent English verbal and written communication skills
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role. We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
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