Company: Premier Research Group
Posted on: November 22, 2021
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
- 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
- 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
- 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
- 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
- Ability to apply clear and consistent performance standards as
well as identify concerns and resolve decisively and objectively
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Keywords: Premier Research Group, Durham , Legal Counsel, Legal , Durham, North Carolina
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