Legal Counsel

Full Time
Remote
Posted
Job description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Legal Counsel to join our Contract Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you’ll be doing:

  • Draft, review, and negotiate a variety of commercial agreements, including but not limited to master services and consultancy services agreements with sponsors for clinical trials, vendor contracts both study and non-study related including but not limited to central laboratory services, medical equipment services, translation services, licensing, and technology agreements.
  • Manage the documentation of contracts from creation to completion to ensure legal and business risk is covered in line with company policy. Draft and implement appropriate processes for contract and legal risk management.
  • Manage legal and regulatory requirements across the US, APAC, Europe and other areas, as needed.
  • Analyze complex legal and factual issues as they arise in relation to Premier’s business, conduct extensive, well-reasoned legal research into areas of risk identified in relation to the business. Ensure compliance with Premier’s Business Rules, especially with respect to approval and signature of all contracts.

What we are searching for:

  • Law degree from an accredited law school and bar membership in at least one jurisdiction along with 5- 8 years of related legal experience (work experience in law firm or as in-house counsel) including international commercial contracting and negotiations; experience in CRO, Clinical trials support, pharmaceutical or other relevant area preferred
  • Knowledge of global privacy and data protection laws and regulations. Knowledge of ICH and local regulatory authority drug research and development regulations and working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
  • Demonstrated strong legal and business judgment to serve as a trusted advisor to colleagues across the business.
  • Proficiency with SalesForce (or other contract management systems) and the Microsoft Office Suite

Why choose Premier Research?

  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

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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