Counsel – Clinical Development, Medical & Regulatory Affairs
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Plainsboro • New Jersey • United States
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Salary
💰 $116,810 - $216,100 per year
About the role
- Responsible for providing legal support to the Clinical Development, Medical & Regulatory Affairs (CMR) organization at Novo Nordisk Inc. (NNI)
- Provide full lifecycle advice and counsel to one or more therapeutic-area teams on matters relating to research and development, scientific exchange, and regulatory strategy and compliance
- Advise and counsel on Medical Affairs strategy and tactics, including scientific exchange, therapeutic-area development, and proposed interactions with healthcare professionals
- Serve as a subject-matter expert on Medical Affairs activities and the principles of scientific exchange
- Draft, negotiate and review a broad set of contractual agreements while ensuring compliance with applicable laws, regulations and industry guidance
- Counsel on research and development-related requirements
- Liaise with and advise CMR functions like Product Safety, Publications and Independent Medical Education
- Collaborate with Legal colleagues and NNI’s Ethics, Compliance & Privacy function
- Assist with the design and implementation of policies, processes, and training
Requirements
- A Juris Doctor (JD) degree or an internationally recognized equivalent and state bar admission required
- 5+ years of experience in a law firm or in-house legal department required
- Relevant experience providing legal advice to life sciences/pharmaceutical industry on research and development preferred
- In-depth knowledge of applicable state and federal laws and regulations
- Demonstrated experience making and communicating risk assessments, identifying and resolving legal and regulatory issues, and making real-time decisions under pressure
- Proven track record as a strong team player with ability to work collaboratively and cross-functionally in a complex organizational structure
- Ability to work independently, proactively and pragmatically, with a focus on results
- Strong problem-solving skills – demonstrates and exercises creativity and initiative
- Advanced written and verbal communications skills, with the ability to collaborate and communicate with stakeholders and at all levels of an organization
Benefits
- medical, dental and vision coverage
- life insurance
- disability insurance
- 401(k) savings plan
- flexible spending accounts
- employee assistance program
- tuition reimbursement program
- voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
- sick time policy
- flexible vacation policy
- parental leave policy
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Juris Doctor (JD)legal advicecontract negotiationregulatory compliancerisk assessmentlegal researchscientific exchangetherapeutic-area developmentpolicy designtraining implementation
Soft skills
collaborationproblem-solvingcommunicationindependenceproactivitycreativityinitiativeteamworkdecision-makingresults-oriented
Certifications
state bar admission