
Legal Counsel – Pharmaceutical
hace 17 horas
KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany and a Liasson office in South Korea, offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.
KYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.
KYMOS GROUP has a young and dynamic staff of more than 200 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.
Kymos is a leading European contract research organization, with laboratories in Spain, Italy and Germany, and a Liaison Office in South Korea, dedicated to providing innovative services to the pharmaceutical industry.
Position 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.
This role will also serve as the Compliance Officer of the Kymos Group and provide legal support across various departments, contributing to the company’s strategic objectives.
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.
- Stay updated on legal developments and trends within the pharmaceutical sector; advise on legal matters related to drug development, regulatory compliance, and marketing practices.
Qualifications:
- 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.
What We Offer:
- Competitive salary (including yearly bonus) and benefits package (partial teleworking, flexible labor time, flexible retribution).
- Opportunities for professional development and advancement.
- International position working in a multicultural environment.
- A collaborative and inclusive work climate.
- The chance to make a meaningful impact on medicines market access.
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