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

Ten23 Health; Basel; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible working arrangements

Competitive pension plan

Annual bonus

Training options

Open culture

Zusammenfassung

ten23 health is a human-centric and sustainable strategic partner for pharma development, manufacturing, and testing. We seek a Paralegal in Basel to support legal and business teams with high-volume commercial contracts while ensuring cGMP compliance and safeguarding IP.

You will draft MSAs, SOWs, NDAs, andQuality Agreements, oversee contract lifecycle, and standardize templates to reflect evolving pharma laws. Strong cross-functional collaboration with QA and legal teams is essential.

Qualifikationen

• Bachelor's degree or Associate's degree with a Paralegal Certificate.
• 3 years minimum in-house legal experience, ideally in CDMO/CRO or life sciences.
• Proficiency with tools like Ironclad, Conga, or DocuSign CLM.
• Basic understanding of FDA 21 CFR regulations and global equivalents.
• Ability to catch conflicting terms between MSAs and Quality Agreements.

Aufgaben

• Draft, review, and track foundational agreements: MSAs, SOWs, NDAs, Quality Agreements.
• Oversee contract lifecycle from intake to approvals, e-signatures, and expiration alerts.
• Maintain and update standard contract templates to reflect pharma laws and policies.
• Support cGMP regulatory compliance and health authority regulations in contract terms.
• Assist QA for client audits or regulatory inspections.
• Support corporate governance: board minutes, entity registrations, licenses.
• Distinguish Background IP and Foreground IP in contracts.
• Review tech transfer documentation related to manufacturing processes.

Kenntnisse

Paralegal

Contract drafting

Regulatory compliance

IP protection

Cross-functional liaison

Legal project management

Ausbildung

Bachelor's degree

Paralegal certificate

Tools

Ironclad

Conga

DocuSign CLM

Jobbeschreibung

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.

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 ([e-mail]) from our Talent team!