Senior Contract and Paralegal Specialist

1 month ago


Durham, North Carolina, United States MedPharm Full time
Job Title: Senior Contract and Paralegal Specialist

Job Summary:

MedPharm is seeking a highly experienced Senior Contract 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.

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 CRO 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.

Requirements:

* Bachelor's degree required. Paralegal certification preferred. Regulatory Affairs Certificate (Medical Device/Pharmaceuticals) or equivalent experience strongly desired.

* 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.

Preferred 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.

Company Overview:

MedPharm is a leading CDMO provider offering a range of services to the pharmaceutical and biotechnology industries. We are committed to delivering high-quality products and services to our clients, while maintaining the highest standards of regulatory compliance and customer satisfaction.

Contact Information:

For more information about this opportunity, please contact our HR department.

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