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Legal Counsel

Company: Premier Research Group
Location: Durham
Posted on: November 22, 2021

Job Description:

Contracts and Legal Affairs Research Triangle Park, North Carolina Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices. We're looking for a knowledgeable and energeticLegal Counselto join our Legal Team! Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority. AsLegal Counsel, you'll have the opportunity to review, negotiate and draft contracts for clients, vendors, and various internal departments. You will manage the contract process end-to-end, working closely with our Business Development, Operations, Finance, Vendor Management, and other teams within the organization. We will need your expertise to provide legal assistance and support to Vice President of Legal Affairs and the Global Data Protection Officer on general corporate legal issues, including global data protection and other policy initiatives. What you'll be doing:

  • Draft, review, and negotiate a variety of commercial agreements, including to master services and consultancy services agreements with sponsors for clinical trials, vendor contracts (for example, 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.
  • Demonstrate strong legal and business judgment and serve as a trusted advisor to colleagues across the business; provide effective and timely communications, information, legal advice and other services to the business on legal and factual issues; 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; advise on general corporate issues.
  • Ensure compliance with Premier's Business Rules, especially with respect to approval and signature of all contracts.
  • Manage legal and regulatory requirements across the US, APAC, Europe and other areas.
  • Assist in Premier's development strategies, identifying, and mitigating risk when it comes to expanding the business.
  • Draft and implement appropriate processes for contract and legal risk management.
  • Participate in hiring and training of new staff; assist in the review of staff performance and make recommendations for improvement or change in staff status; conduct internal trainings with contracts team and other employees.
  • Participate in client presentations and/or bid defense meetings, as required. You'll need this to be considered:
    • 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 in order to serve as a trusted advisor to colleagues across the business.
    • Proficiency with SalesForce (or other contract management systems) and the Microsoft Office Suite
    • Read, write, and speak fluent English; fluent in host country language
    • Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach; excellent team player who encompasses the management skills to motivate, enthuse and lead teams; accountable, dependable and strong commitment
    • Excelled organizational and time-management skills with the ability to multitask, meet deadlines and work effectively in a fast-paced environment with competing priorities
    • Self-starter with common sense and able to act on own initiative
    • Ability to apply clear and consistent performance standards as well as identify concerns and resolve decisively and objectively You have been redirected to a Premier Research job page

Keywords: Premier Research Group, Durham , Legal Counsel, Legal , Durham, North Carolina

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