Contracts and Paralegal Specialist

Medpharm - Us - Durham, NC

Full-time - Mid Level

Durham, NC

Computer and Electronic Product Manufacturing

About the position

The Contracts and Paralegal Specialist will play a crucial role in the legal team of a fast-paced Contract Development and Manufacturing Organization (CDMO). This position focuses on managing contracts, ensuring compliance with industry regulations, and providing legal support for corporate transactions. The ideal candidate will have extensive experience in the pharmaceutical and biotechnology sectors, with a strong emphasis on contract management and regulatory affairs.

Responsibilities

• Draft, review, and revise various contracts including master services agreements, confidentiality agreements, and supply agreements.
• Manage the contract lifecycle from initial review to execution, amendments, and renewals.
• Maintain contract records and database for easy access and tracking of contract milestones.
• Assist in the preparation and review of legal documents for corporate transactions and regulatory matters.
• Support the legal team in due diligence activities and ensure compliance with contractual obligations.
• Research legal issues relevant to the CDMO industry, including intellectual property and regulatory requirements.
• Ensure adherence to industry regulations such as FDA and GMP standards.
• Support compliance with data protection regulations like GDPR and HIPAA.
• Assist with audits and regulatory inspections, maintaining proper legal documentation.
• Collaborate with business development, project management, and regulatory teams to ensure legal alignment with client projects.
• Coordinate with external legal counsel and act as a liaison between internal teams and outside legal resources.
• Provide training on contract processes and legal best practices to internal teams.
• Maintain organized legal files and documentation, ensuring confidentiality.

Requirements

• Bachelor's degree required.
• 5+ years of experience in contract management or paralegal roles within pharmaceutical, biotechnology, or CRO industries.
• Extensive knowledge of clinical research settings and regulatory affairs.
• Familiarity with privacy laws (GDPR, HIPAA) and risk management frameworks.
• Expertise in contract drafting, review, and negotiation.
• Strong project management and process improvement skills.
• Excellent communication, collaboration, and problem-solving abilities.
• Proficiency with contract management software and legal documentation systems.

Nice-to-haves

• Paralegal certification preferred.
• Regulatory Affairs Certificate (Medical Device/Pharmaceuticals) or equivalent experience strongly desired.

Benefits

• Competitive salary range of $93.5K - $118K per year.