Principal Legal Counsel for Pharmaceutical Group
hace 3 horas
About Kymos Group
Kymos Group is a medium-sized Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany. Our company is committed to providing high-quality services to the life sciences industry. Our laboratories are GMP and GLP certified and GCP compliant, having been successfully inspected by EMA, FDA, and ANVISA.
Job Overview
We are seeking a skilled Legal Counsel to develop this role for all Group companies. The ideal candidate will have 3-4 years of experience in the pharmaceutical or biotech industries and a deep understanding of regulatory compliance, intellectual property, and contract law.
Key Responsibilities
- Serve as the Compliance Officer at Corporate level, ensuring adherence to all applicable laws, regulations, and internal policies.
- Coordinate the legal practices between headquarters and affiliates, collaborating with external legal services of each legal entity, when necessary.
- Draft, review, and negotiate business contracts, including NDAs, MSAs, QTAs, clinical trial agreements, and partnership agreements.
- Draft, review, and negotiate general supply agreements, purchase contracts, and vendor agreements.
- Ensure compliance with data protection laws and regulations, including GDPR, and advise on data privacy matters.
- Coordinate with the Board Secretary on corporate governance matters, including the preparation of corporate documents, minutes, resolutions, powers of attorney, and other related matters.
- Oversee the management of insurance policies, ensuring adequate coverage for various legal and operational risks.
- Collaborate with Human Resources in managing the relationship with the works council, addressing labor relations issues and ensuring compliance with employment laws.
- Represent the company in legal disputes and coordinate with external counsel as needed.
Requirements
- Licensed to practice law.
- 3-5 years of experience in a legal role within the pharmaceutical or biotech industry.
- Substantial understanding of EMA, FDA regulations, legal compliance, and contract law.
- Proven experience drafting and negotiating NDAs, MSAs, and QTAs.
- Familiarity with risk management and risk assessment.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
- Effective communication skills, both written and verbal.
- Excellent drafting and negotiation skills in English.
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