Consultant

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 Built for You. 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.

• We are Built by You. Your ideas influence the way we work, and your voice matters here.

• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech™. Join us and build your future here.

What you'll be doing:

• Provide ad-hoc, as-needed, regulatory guidance across critical therapeutic areas as a Consultant
• Provide deep expertise and help navigate complex regulatory landscapes for specified therapeutic areas
• Consult in domain areas to enhance service offerings
• Leverage specialized knowledge, contributing to diverse and meaningful clinical trials
• Flexibility to work on projects that align with expertise and availability

What we are searching for: 

• Minimum BS degree in a science-related field plus 3+ years as a Regulatory Project Manager or equivalent in the clinical research industry
• Prior experience working directly for the FDA required
• Demonstrated expertise in either of the following therapeutic areas required: Neuroscience, Pediatrics, Rare Disease or Women's Health
• Advanced knowledge of US and International regulatory requirements and exceptional understanding of global regulatory pathways and agency interactions
• Ability to work independently and provide expert guidance on a flexible, project-by-project basis

#LI-TW1

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