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

ten23 health; Basel; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Career development opportunity

Flexible working arrangements

Learning culture & training options

Competitive pension plan

Annual bonus

Zusammenfassung

ten23 health in Basel seeks an experienced Paralegal to support the legal and business teams in drafting, reviewing, and tracking a high volume of commercial contracts. You will ensure compliance with cGMP and pharma regulations, manage IP boundaries, and navigate tech transfer and manufacturing liabilities in a B2B setting.

The role emphasizes collaboration across QA, quality, and regulatory functions, with responsibilities spanning MSAs, SOWs, NDAs, and quality agreements, and ensuring

Qualifikationen

• Bachelor’s degree or Associate’s degree with a Paralegal Certificate.
• 3 years minimum in-house legal experience, ideally in a CDMO/CRO or life sciences environment.
• Proficiency with Ironclad, Conga, or DocuSign CLM.
• Familiarity with FDA 21 CFR regulations and global equivalents.
• Ability to bridge scientific, quality, business development, and legal teams.

Aufgaben

• Draft and negotiate foundational agreements: MSAs, SOWs, NDAs, and Quality Agreements.
• Manage the contract lifecycle from intake to approvals, signatures, and expirations.
• Standardize and update contract templates to reflect evolving pharma laws.
• Support cGMP compliance and regulatory inspections readiness.
• Protect IP by distinguishing Background IP and Foreground IP.
• Review tech transfer documentation between client and CDMO.
• Coordinate with QA and legal to resolve contract disputes.
• Track corporate filings and maintain facility licenses.

Jobbeschreibung

About Us

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.

Your mission

Location: Basel
FTE: 80–100%
We are looking for aParalegalsupports 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.

Your profile

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.

Why us?

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.

Contact

For more information and clarification, please connect Amrith ([e-mail]) from our Talent team!