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

h3About Us /h3 pten23 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. /p h3Your mission /h3 pbLocation: /b Baselbr/bFTE: /b 80–100%br/We are looking for abParalegal /bsupports 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/Your responsibilities will include, /p h3Contract Management Drafting /h3 ul liDraft 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 liManage the contract lifecycle: Oversee the legal database from initial intake and drafting through approvals, electronic signatures, and expiration alerts. /li liStandardize templates: Maintain and update standard contract templates to adapt to changing pharmaceutical laws and corporate policies. /li /ul h3Regulatory Corporate Compliance /h3 ul liSupport cGMP compliance: Ensure all contract terms align with Current Good Manufacturing Practices (cGMP) and health authority regulations. /li liAudit preparation: Assist internal quality teams in prepping documentation for client audits or regulatory inspections (e.g., FDA inspections). /li liCorporate governance: Assist with corporate secretarial duties, including organizing board minutes, maintaining entity registrations, and managing operational licenses. /li /ul h3IP Protection Technical Support /h3 ul liSafeguard 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 liTech transfer documentation: Review legal documentation related to the transfer of manufacturing processes from the client to the CDMO facility. /li /ul h3Day-to-Day Tasks /h3 ul liReviewing 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 liLiaising between the Quality Assurance (QA) team and the client's legal counsel to resolve a dispute over a clause in a Quality Agreement. /li liTracking corporate filings for multiple manufacturing sites and labs to keep facility licenses current. /li liManaging the legal intake portal, prioritizing contract requests based on manufacturing timelines and slot availability. /li /ul h3Your profile /h3 pWe 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.br/The ideal candidate possesses: /p ul liBachelor’s degree or an Associate’s degree with a Paralegal Certificate. /li li3 years minimum in-house legal experience, ideally within a CDMO, CRO (Contract Research Organization), or a broader life sciences/biotech environment. /li liProficiency with tools like Ironclad, Conga, or DocuSign CLM. /li liBasic understanding of the drug development lifecycle, specifically "Drug Product" (vials, syringes, oral solids, tech transfers) versus "Drug Substance" (API manufacturing). /li liFamiliarity with FDA 21 CFR regulations and global equivalents. /li liEssential for catching conflicting terms between MSAs and Quality Agreements. /li liAbility to act as a bridge between scientific, quality, business development, and legal teams. /li /ul h3Why us? /h3 pWe offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.br/Here’s what sets ten23 apart: /p ul liA valuable and impactful career development opportunity in an inspiring environment /li liFlexible working arrangements and environment with an open culture and diverse workforce /li liThe opportunity to work with and learn from highly qualified and experienced employees /li liOur learning and self-developing culture offers a wide range of training options /li liCompetitive pension fund plan, annual bonus, and other financial and non-financial benefit /li /ul pAt 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. /p h3Contact /h3 pFor more information and clarification, please connect Amrith ( ) from our Talent team! /p #J-18808-Ljbffr