Job Title

Job Title: Legal & Contract Manager – Biologics & CRO (Legal Focus)Location: Vapi, GujaratAbout the RoleWe are seeking an experienced Contract Manager with a strong background in legal writing to support global contract management for clinical research organizations (CROs) and pharmaceutical/biologics programs. The role involves drafting, reviewing, and negotiating complex agreements within regulated environments, collaborating cross-functionally with legal, clinical, procurement, and business development teams.Key ResponsibilitiesDraft, review, and negotiate a wide range of agreements including: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.)Liaise with internal legal counsel, investigators, sponsors, and CRO partnersTrack contract timelines, approvals, renewals, and change ordersMaintain contract templates and standard terms in line with global guidelinesMitigate legal and financial risks while safeguarding organizational interestsSupport audits and due diligence processes related to contracts and vendor relationshipsPreferred QualificationsBachelor’s/Master’s Degree in Law, Life Sciences, Pharmacy, or related field5–10 years of experience in contract management within CROs, biologics and biotech industryStrong understanding of clinical development phases and regulatory frameworksExceptional legal writing, communication, and negotiation skillsProficiency with contract management systems (e.g., Medidata, Veeva Vault, or equivalent)Nice to HaveCertification in Contract Law or Clinical Trial RegulationsExposure to biologics, gene therapy, or oncology-related trialsFamiliarity with global regulatory authorities and submission protocols