Job
Description
As a Legal & Contract Manager for Biologics & CRO, your role will involve supporting global contract management for clinical research organizations (CROs) and pharmaceutical/biologics programs. You will be responsible for drafting, reviewing, and negotiating a variety of agreements within regulated environments. Collaboration with legal, clinical, procurement, and business development teams will be essential in this role. Key Responsibilities: - Draft, review, and negotiate agreements such as Clinical Trial Agreements (CTAs), Confidentiality Disclosure Agreements (CDAs), Master Service Agreements (MSAs), Statements of Work (SOWs), Licensing, Consulting & Collaboration Agreement. - Ensure compliance with internal policies and external regulations (ICH-GCP, FDA, EMA, etc.). - Collaborate with internal legal counsel, investigators, sponsors, and CRO partners. - Track contract timelines, approvals, renewals, and change orders. - Maintain contract templates and standard terms aligning with global guidelines. - Mitigate legal and financial risks while safeguarding organizational interests. - Support audits and due diligence processes related to contracts and vendor relationships. Qualifications Required: - Bachelor's/Master's Degree in Law, Life Sciences, Pharmacy, or related field. - 5-10 years of experience in contract management within CROs, biologics, and biotech industry. - Strong understanding of clinical development phases and regulatory frameworks. - Exceptional legal writing, communication, and negotiation skills. - Proficiency with contract management systems (e.g., Medidata, Veeva Vault, or equivalent). In addition to the above, it is preferred to have: - Certification in Contract Law or Clinical Trial Regulations. - Exposure to biologics, gene therapy, or oncology-related trials. - Familiarity with global regulatory authorities and submission protocols. As a Legal & Contract Manager for Biologics & CRO, your role will involve supporting global contract management for clinical research organizations (CROs) and pharmaceutical/biologics programs. You will be responsible for drafting, reviewing, and negotiating a variety of agreements within regulated environments. Collaboration with legal, clinical, procurement, and business development teams will be essential in this role. Key Responsibilities: - Draft, review, and negotiate agreements such as Clinical Trial Agreements (CTAs), Confidentiality Disclosure Agreements (CDAs), Master Service Agreements (MSAs), Statements of Work (SOWs), Licensing, Consulting & Collaboration Agreement. - Ensure compliance with internal policies and external regulations (ICH-GCP, FDA, EMA, etc.). - Collaborate with internal legal counsel, investigators, sponsors, and CRO partners. - Track contract timelines, approvals, renewals, and change orders. - Maintain contract templates and standard terms aligning with global guidelines. - Mitigate legal and financial risks while safeguarding organizational interests. - Support audits and due diligence processes related to contracts and vendor relationships. Qualifications Required: - Bachelor's/Master's Degree in Law, Life Sciences, Pharmacy, or related field. - 5-10 years of experience in contract management within CROs, biologics, and biotech industry. - Strong understanding of clinical development phases and regulatory frameworks. - Exceptional legal writing, communication, and negotiation skills. - Proficiency with contract management systems (e.g., Medidata, Veeva Vault, or equivalent). In addition to the above, it is preferred to have: - Certification in Contract Law or Clinical Trial Regulations. - Exposure to biologics, gene therapy, or oncology-related trials. - Familiarity with global regulatory authorities and submission protocols.
