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

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients. 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. We are looking for a motivated and committed professional who is ready to actively grow with us, combining in-depth technical knowledge with a pronounced cooperative spirit.The ideal candidate possesses: - Bachelor’s degree or an Associate’s degree with a Paralegal Certificate. - 3 years minimum in-house legal experience, ideally within a CDMO, CRO (Contract Research Organization), or a broader life sciences/biotech environment. - Proficiency with tools like Ironclad, Conga, or DocuSign CLM. - Basic understanding of the drug development lifecycle, specifically "Drug Product" (vials, syringes, oral solids, tech transfers) versus "Drug Substance" (API manufacturing). - Familiarity with FDA 21 CFR regulations and global equivalents. - Essential for catching conflicting terms between MSAs and Quality Agreements. - Ability to act as a bridge between scientific, quality, business development, and legal teams. We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.   Here's what sets ten23 apart: - A valuable and impactful career development opportunity in an inspiring environment - Flexible working arrangements and environment with an open culture and diverse workforce   - The opportunity to work with and learn from highly qualified and experienced employees - Our learning and self-developing culture offers a wide range of training options   - Competitive pension fund plan, annual bonus, and other financial and non-financial benefit At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws. For more information and clarification, please connect Amrith ([email protected]) from our Talent team!