indegene usaFoster City, CA
Legal SME – Contracts & Materials Review
Legal SME – Contracts & Materials Review
Legal SME – Contracts & Materials Review
indegene usaFoster City, CA
today
Other Management Consulting ServicesAdministrative Management and General Management Consulting ServicesPharmaceutical Preparation Manufacturing
Apply for this role →Title: Lead Business Consultant – Legal, CLM & Content Transformation
Location: Foster City, CA | Hybrid(3 days/week)
Contract: 6 Months
Experience: 10+ years of relevant experience
Domain: Life Sciences / Pharmaceutical – Legal Operations, Contract Lifecycle Management and Medical, Legal & Regulatory ReviewRole Summary
We are seeking a senior consulting professional to lead operating-model and process transformation across Contract Lifecycle Management (CLM), Medical, Legal and Regulatory (MLR) review, and related legal and compliance operations. The individual will combine strong legal and contracting acumen with proven CLM implementation experience, practical pharmaceutical MLR process expertise and the ability to guide senior stakeholders through business and technology change. The role will translate business objectives and legal, medical, regulatory and compliance requirements into effective processes, governance and technology-enabled solutions. The individual will adopt business and functional workstreams from discovery and solution assessment through implementation, adoption and measurement of outcomes, supported by designated technical and domain specialists.
Key Responsibilities:
Operating-Model and Process Transformation
Assess existing processes, organizational responsibilities, governance, systems and service-delivery models across contracting and promotional-content review. Lead discovery workshops and document current processes, identifying bottlenecks, control gaps, duplication and opportunities for standardization. Design future-state workflows, responsibility matrices, approval authorities, escalation paths and exception-management procedures. Develop transformation roadmaps and business cases balancing business value, legal and compliance requirements, cost and implementation complexity. Establish baseline performance measures and improvement targets. Legal Acumen and CLM Implementation
Lead CLM business and functional workstreams covering intake, drafting, negotiation, approval, execution, repository management, obligations, renewals and termination. Understand commercial contract provisions and their operational implications, including confidentiality, data protection, intellectual property, liability, indemnities, payment and termination. Translate counsel-approved contractual positions into templates, clause libraries, negotiation playbooks, fallback clauses, deviation thresholds and approval workflows. Define contract types, metadata, risk classifications, access permissions, audit trails and reporting requirements. Verify through scenario-based testing that configured solutions correctly apply approved contracting rules, including non-standard terms and exceptions. Guide contract migration, metadata validation, obligation tracking and integration requirements with procurement, finance, CRM and electronic-signature systems. Identify matters requiring legal judgment and secure appropriate counsel input and approval. MLR and Content Operating Models
Assess and improve pharmaceutical promotional-material review processes, including submission, review, approval, version control, expiry and withdrawal. Work with Medical, Legal, Regulatory and Commercial stakeholders to improve review quality, accountability and turnaround. Translate requirements for claims substantiation, reference management, content reuse and local-market adaptation into processes and functional specifications. Evaluate risk-based review pathways and modular-content approaches with designated subject-matter experts. Maintain appropriate review, approval, traceability and audit controls throughout process changes. Technology, AI and Solution Assessment
Translate approved process designs into business requirements, user stories, acceptance criteria and functional specifications. Lead functional fit-gap assessments, vendor demonstrations and business-process inputs to platform selection. Develop build-versus-buy recommendations covering functional fit, integrations, implementation effort, total cost, scalability and ongoing support. Partner with architects and implementation teams on configuration, integrations, data migration and solution design. Assess AI-assisted use cases, including clause extraction, contract-deviation identification, obligation extraction and content-review support. Evaluate proposed AI solutions against representative scenarios, considering accuracy, missed risks, unsupported outputs, confidentiality, traceability and human-review requirements. Define measurable pilot outcomes and recommendations for adoption, further testing or rejection. Implementation, Adoption and Delivery Accountability
Own business and functional workstream deliverables, milestones, acceptance criteria and handover through go-live and stabilization. Maintain traceability between approved requirements, configuration decisions and testing outcomes. Lead business readiness and user acceptance testing, including exceptions and negative test cases; support applicable validation activities with specialist teams. Coordinate delivery dependencies, issue resolution and deployment readiness. Develop SOPs, playbooks, training materials and change-adoption plans. Measure outcomes such as contract cycle time, review turnaround, rework, control effectiveness, obligation visibility and user adoption. Stakeholder and Consulting Leadership
Independently facilitate workshops and drive decisions with senior Legal, Compliance, Medical, Regulatory, Commercial and Technology stakeholders. Present recommendations, alternatives, risks and implementation priorities clearly. Lead and mentor business analysts and consultants, coordinating implementation teams and domain specialists. Contribute to engagement scoping, proposals, effort estimates and reusable delivery methods. Obtain decisions and approvals from designated client process owners and maintain a documented decision record. Required Qualifications and Experience
10+ years of relevant experience in business consulting, legal operations, contract management or technology-enabled transformation. Demonstrated experience independently leading complex transformation initiatives, business or functional workstreams and senior client stakeholders. Relevant experience delivering transformation initiatives within pharmaceutical or life sciences organizations. Strong legal and contracting acumen, evidenced by substantive experience interpreting commercial contracts and translating counsel-approved legal requirements into operational processes and system controls. Business or functional leadership of at least one CLM implementation through go-live, covering requirements, contracting playbooks, workflow design, testing and adoption. Practical experience assessing or improving pharmaceutical MLR processes, with an understanding of the respective responsibilities of Medical, Legal and Regulatory reviewers. Proven ability to develop operating models, process maps, governance frameworks and implementable functional requirements. Ability to assess AI-enabled use cases and define evaluation criteria, human oversight and acceptance requirements. Strong analytical, workshop facilitation, communication, stakeholder-management and delivery-leadership skills. Bachelor’s degree in law, business, life sciences or a related discipline. Legal qualification: A law degree is strongly preferred. Candidates without a law degree must demonstrate substantive experience interpreting commercial contracts, developing contracting playbooks and translating legal requirements into CLM implementations. Platform administration or project coordination alone is insufficient. Preferred Experience
Experience with an enterprise CLM platform, such as Icertis, Ironclad, Docusign CLM, Agiloft or an equivalent solution. Experience with Veeva Vault PromoMats or an equivalent pharmaceutical content-review platform. Deeper expertise in content operating models, claims management, modular content and global-to-local content reuse. Experience evaluating or implementing AI-assisted contracting or content-review solutions. Experience with global operating models, contract migration, post-signature obligation management and organizational change. Relevant platform certifications. Decision-Making Responsibilities
The individual must understand and constructively challenge legal and contracting requirements and translate approved positions into effective processes and system controls. Designated counsel retains responsibility for legal advice and approval of legal positions. Authorized Medical, Legal and Regulatory reviewers retain responsibility for substantive content approval. Client process owners retain final governance and risk-acceptance authority. The role owns business and functional delivery, supported by specialists responsible for technical architecture, development, security and applicable validation.
Also on the board Same function, level within a rung
Level
Manager
Location
Foster City, CA
Occupation
Compliance Managers
Industry
Other Management Consulting Services
Posted
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