About this role
About Us <span style="color:rgb(66,66,66);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;">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.</span> Your mission <strong>Location:</strong> Basel<br><strong>FTE:</strong> 80–100%<br><br>We are looking for a <strong>Paralegal </strong>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.<br> <br>Your responsibilities will include,<br> <br>Contract Management & Drafting<br><ul><li>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).</li><li>Manage the contract lifecycle: Oversee the legal database from initial intake and drafting through approvals, electronic signatures, and expiration alerts.</li><li>Standardize templates: Maintain and update standard contract templates to adapt to changing pharmaceutical laws and corporate policies.</li></ul>Regulatory & Corporate Compliance<br><ul><li>Support cGMP compliance: Ensure all contract terms align with Current Good Manufacturing Practices (cGMP) and health authority regulations.</li><li>Audit preparation: Assist internal quality teams in prepping documentation for client audits or regulatory inspections (e.g., FDA inspections).</li><li>Corporate governance: Assist with corporate secretarial duties, including organizing board minutes, maintaining entity registrations, and managing operational licenses.</li></ul>IP Protection & Technical Support<br><ul><li>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).</li><li>Tech transfer documentation: Review legal documentation related to the transfer of manufacturing processes from the client to the CDMO facility.</li></ul>Day-to-Day Tasks<br><ul><li>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.</li><li>Liaising between the Quality Assurance (QA) team and the client's legal counsel to resolve a dispute over a clause in a Quality Agreement.</li><li>Tracking corporate filings for multiple manufacturing sites and labs to keep facility licenses current.</li><li>Managing the legal intake portal, prioritizing contract requests based on manufacturing timelines and slot availability.</li></ul> Your profile <span style="color:rgb(66,66,66);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;">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.</span><br style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);"><br style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);"><span style="color:rgb(66,66,66);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;">The ideal candidate possesses:</span><br><ul><li>Bachelor’s degree or an Associate’s degree with a Paralegal Certificate.</li><li>3 years minimum in-house legal experience, ideally within a CDMO, CRO (Contract Research Organization), or a broader life sciences/biotech environment.</li><li>Proficiency with tools like Ironclad, Conga, or DocuSign CLM.</li><li>Basic understanding of the drug development lifecycle, specifically "Drug Product" (vials, syringes, oral solids, tech transfers) versus "Drug Substance" (API manufacturing).</li><li>Familiarity with FDA 21 CFR regulations and global equivalents.</li><li>Essential for catching conflicting terms between MSAs and Quality Agreements.</li><li>Ability to act as a bridge between scientific, quality, business development, and legal teams.</li></ul> Why us? <span style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;">We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.</span><br style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);"><span style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;"> </span><br style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);"><span style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;"> Here's what sets ten23 apart:</span><br style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);"><ul style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;margin:8px 0px;padding:0px 0px 0px 24px;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);"><li style="border:0px solid rgb(229,231,235);font-family:inherit;list-style-type:disc;margin-bottom:4px;">A valuable and impactful career development opportunity in an inspiring environment</li><li style="border:0px solid rgb(229,231,235);font-family:inherit;list-style-type:disc;margin-bottom:4px;">Flexible working arrangements and environment with an open culture and diverse workforce </li><li style="border:0px solid rgb(229,231,235);font-family:inherit;list-style-type:disc;margin-bottom:4px;">The opportunity to work with and learn from highly qualified and experienced employees</li><li style="border:0px solid rgb(229,231,235);font-family:inherit;list-style-type:disc;margin-bottom:4px;">Our learning and self-developing culture offers a wide range of training options </li><li style="border:0px solid rgb(229,231,235);font-family:inherit;list-style-type:disc;margin-bottom:4px;">Competitive pension fund plan, annual bonus, and other financial and non-financial benefit </li></ul><span style="border:0px solid rgb(229,231,235);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;color:rgb(66,66,66);font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;">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.</span> Contact <span style="color:rgb(66,66,66);font-family:Arial, Helvetica, sans-serif, Inter, Arial, Helvetica, sans-serif;font-size:14px;font-style:normal;font-weight:400;text-transform:none;background-color:rgb(255,255,255);display:inline;">For more information and clarification, please connect Amrith ([email protected]) from our Talent team!</span>