Paralegal, Basel e/v/e/r/y/o/n/e

Location: Basel
FTE: 80–100%

We are looking for a Paralegal supports the legal and business teams by drafting, reviewing, and tracking a high volume of commercial contracts. They ensure compliance with strict pharmaceutical regulations (FDA, EMA, cGMP) and safeguard proprietary client data and technology. Unlike general paralegals, this role requires a deep understanding of the tech transfer process, manufacturing liabilities, and intellectual property (IP) boundaries in a business-to-business (B2B) setting.
 
Your responsibilities will include,
 
Contract Management & Drafting

• Draft and negotiate foundational agreements: Handle Master Services Agreements (MSAs), Statements of Work (SOWs), Non-Disclosure Agreements (NDAs), and Quality Agreements (Quality Agreements are highly critical in DP manufacturing).
• Manage the contract lifecycle: Oversee the legal database from initial intake and drafting through approvals, electronic signatures, and expiration alerts.
• Standardize templates: Maintain and update standard contract templates to adapt to changing pharmaceutical laws and corporate policies.

Regulatory & Corporate Compliance

• Support cGMP compliance: Ensure all contract terms align with Current Good Manufacturing Practices (cGMP) and health authority regulations.
• Audit preparation: Assist internal quality teams in prepping documentation for client audits or regulatory inspections (e.g., FDA inspections).
• Corporate governance: Assist with corporate secretarial duties, including organizing board minutes, maintaining entity registrations, and managing operational licenses.

IP Protection & Technical Support

• Safeguard intellectual property: Ensure contracts clearly distinguish between "Background IP" (what the client or CDMO owned before working together) and "Foreground IP" (new formulations or methods developed during the DP process).
• Tech transfer documentation: Review legal documentation related to the transfer of manufacturing processes from the client to the CDMO facility.

Day-to-Day Tasks

• Reviewing a new SOW for a client's phase III clinical trial drug product batch filling to ensure the timelines, pricing, and liabilities match the master agreement.
• Liaising between the Quality Assurance (QA) team and the client's legal counsel to resolve a dispute over a clause in a Quality Agreement.
• Tracking corporate filings for multiple manufacturing sites and labs to keep facility licenses current.
• Managing the legal intake portal, prioritizing contract requests based on manufacturing timelines and slot availability.