Overview
Contract Legal Reviewer Jobs in Boston, MA at Planet Pharma
Title: Contract Legal Reviewer
Company: Planet Pharma
Location: Boston, MA
Position DescriptionPosition titleContract Clinical Legal Document ReviewerReports toDirectly to Global Clinical LeadDepartmentClinical Operations DescriptionWe are seeking a highly skilled and proactive Contract Clinical Document Legal Reviewer to join our team. In this role, you will provide specialized legal support focused on the review, consultation and negotiation (as needed) of core global clinical trial documents. The ideal candidate bridges the gap between legal, clinical, and regulatory requirements, ensuring that all documents are compliant with ICH-GCP guidelines, FDA regulations, and company policies. This is a remote position requiring high attention to detail and the ability to work independently.Primary responsibilities
- Contract Review & Negotiation: Act as Sponsor Legal representative for reviewing, advising and negotiating (as needed) global clinical trial agreements (CTAs), Confidentiality Disclosure Agreements (CDAs), Master Services Agreements (MSAs), Informed Consent Forms (ICFs), CRO agreements & vendor contracts.
- Clinical Document Compliance: Review and advise on clinical documents for compliance with local, state, and international laws.
- Risk Management: Identify, mitigate, and escalate legal risks related to indemnification, liability, intellectual property, data privacy, and publication rights, as necessary.
- Stakeholder Liaison: Partner with internal clinical operations, R&D, procurement, Legal and regulatory teams and externally with CRO and specialty vendors, where appropriate.
- Process Improvement: If required, contribute to the development of templates, playbooks, and standardized processes to increase contract efficiency.
Required qualifications
- Education: Juris Doctorate (JD) degree from an accredited law school.
- Experience: 5+ years of post-qualification legal experience, with at least 3 years focusing on clinical trial agreements and research contracts (biotech, pharma, or CRO experience preferred).
- Regulatory Knowledge: Deep understanding of FDA regulations, ICH-GCP Guidelines, and patient data privacy rules.
- Negotiation Skills: Strong negotiation skills, capable of interacting directly with site negotiators, academic institutions, and vendors.
- Technical Skills: Proficiency in contract management software and Microsoft Office Suite.
Additional skills and attributes
- Excellent written and verbal communication skills.
- Strong analytical and critical thinking abilities.
- Ability to work independently as a contractor and adapt to fast-paced environments.
- High attention to detail and organizational skills.
