Duties and Responsibilities: We are seeking a proactive and contract-savvy Paralegal to join our administrative team, supporting a growing and innovative medical device organization. This role will focus on managing, drafting, and negotiating a wide array of contracts critical to our clinical, research, commercial, and operational success. The ideal candidate brings deep experience supporting legal operations within highly regulated environment and thrives on cross-functional collaboration in a mission-driven setting. The ideal person for this position will be self-driven, proactive, flexible, and detailed-oriented and who always endeavors to go the extra mile. This person thrives in a fast-paced environment and has a passion for healthcare with minimal direction. Job duties include: Contract Management & Drafting - Prepare, review, and revise contracts typical to the medical device and biotech sectors, including:
- Clinical Trial Agreements (CTAs)
- Investigator-Initiated Studies (IIS)
- Vendor and Manufacturing Agreements
- Quality and Supply Agreements
- Research Collaboration Agreements
- NDAs, MSAs, and SOWs
- Ensure contracts reflect industry-specific regulatory and operational risks, including FDA and HIPAA considerations.
- Maintain and update template contracts to reflect current legal and compliance standards.
Contract Lifecycle Support - Oversee the end-to-end contract lifecycle from intake to execution, using DocuSign.
- Track contract renewals, expirations, and financial obligations using DocuSign.
- Coordinate signature processes, archiving, and DocuSign management to ensure audit-readiness.
Legal & Regulatory Compliance - Aid in the implementation of legal SOPs and internal training initiatives related to contracts and compliance.
Cross-Functional Collaboration - Triage and escalate complex legal questions to in-house counsel as appropriate.
- Participate in cross-functional meetings to provide legal process guidance and timeline coordination.
Works cooperatively and collaboratively with other executives and staff members to create a high-functioning team that sets and achieves goals. |
Work Experience: - Prior in-house legal experience in medical device, biotech, or life sciences sectors highly preferred.
- Familiarity with industry-specific agreements and regulatory frameworks (FDA, GCP, GMP, GDPR, HIPAA).
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Knowledge, Skills & Abilities: - Proven ability to work with technical and clinical documents.
- Detail-oriented with strong organizational and contract analytics skills.
- Excellent communication and writing abilities.
- Experience with contract management systems and e-signature platforms (e.g., DocuSign).
- High integrity, discretion, and the ability to manage sensitive information responsibly.
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Physical Requirements: - Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
- Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
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