Paralegal
Durham, NC
Full Time
Mid Level
Job Purpose:
We are seeking a highly experienced Contracts and Paralegal Specialist to join our dynamic legal team in a fast-paced, high-volume CDMO environment. This individual will have a demonstrated history of working within the pharmaceutical, biotechnology, and CRO industries, with a strong background in contract management, clinical research, and regulatory affairs. The role requires extensive experience in managing business operations, streamlining processes, and ensuring compliance with privacy laws and industry regulations. The ideal candidate is a resourceful problem solver with excellent communication, collaboration, and risk management skills.
Summary of Key Responsibilities:
We are seeking a highly experienced Contracts and Paralegal Specialist to join our dynamic legal team in a fast-paced, high-volume CDMO environment. This individual will have a demonstrated history of working within the pharmaceutical, biotechnology, and CRO industries, with a strong background in contract management, clinical research, and regulatory affairs. The role requires extensive experience in managing business operations, streamlining processes, and ensuring compliance with privacy laws and industry regulations. The ideal candidate is a resourceful problem solver with excellent communication, collaboration, and risk management skills.
Summary of Key Responsibilities:
- Contract Management:
- Draft, review, and revise a variety of contracts, including master services agreements (MSAs), confidentiality agreements (CDAs/NDAs), quality agreements, and supply/manufacturing agreements.
- Ensure compliance with company policies and legal standards.
- Manage the contract lifecycle, from initial review to execution, amendments, and renewals.
- Maintain contract records and database, ensuring easy access and tracking of contract milestones and key obligations.
- Legal Support:
- Assist in the preparation and review of legal documents for various corporate transactions and regulatory matters.
- Support the legal team in due diligence activities, ensuring compliance with contractual terms and obligations.
- Research legal issues relevant to the CDMO industry, such as intellectual property, regulatory requirements, and commercial laws.
- Compliance and Risk Management:
- Ensure the company's adherence to industry regulations (FDA, EMA, etc.), including Good Manufacturing Practice (GMP) and other applicable standards.
- Support compliance with data protection regulations (GDPR, HIPAA, etc.) and help implement privacy-related policies and procedures.
- Assist with audits and regulatory inspections, maintaining proper legal documentation and records.
- Cross-Departmental Collaboration:
- Collaborate with business development, project management, and regulatory teams to ensure legal alignment with ongoing client projects.
- Coordinate with external legal counsel when necessary and act as a liaison between internal teams and outside legal resources.
- Provide training on contract processes and legal best practices to internal teams.
- Document Management:
- Maintain organized legal files and documentation, ensuring confidentiality and proper archiving.
- Education: Bachelor's degree required. Paralegal certification preferred. Regulatory Affairs Certificate (Medical Device/Pharmaceuticals) or equivalent experience strongly desired.
- Experience:
- 5+ years of experience in contract management or paralegal roles within pharmaceutical, biotechnology, or CRO industries.
- Extensive knowledge of clinical research settings, regulatory affairs, and high-volume contract management.
- Familiarity with privacy laws (GDPR, HIPAA) and risk management frameworks.
- Skills:
- Expertise in contract drafting, review, and negotiation.
- Strong project management and process improvement skills, with the ability to handle multiple priorities in a time-sensitive environment.
- Excellent communication, collaboration, and problem-solving abilities.
- Proficiency with contract management software and legal documentation systems.
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