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Associate Director, Egme Lead Mexico
hace 2 semanas
**Summary**:
Provides contracting life cycle management and business solutions optimizing operational expertise to US MA US Medical Affairs, partnering with all areas in the end-to-end planning process and execution. Responsible for managing cross-functional teams in evidence generation and medical excellence requiring alignment of team goals with organizational objectives, fostering collaboration, ensuring quality and compliance, and encouraging innovation. It also includes engaging stakeholders, managing resources efficiently, and monitoring team performance to achieve strategic outcomes.
**About the Role**:
**Key Responsibilities**:
- **Contract Life Cyle Management**:Implements best-in-class contract management processes and tools in the day-to-day practice. Provides continuous feedback from the execution/implementation to align best practices with business needs. Reports on set cadence tracking metrics and suggested process improvements.
- ** Contract**: Authors, negotiates, executes, and manages the contractual documents needed to affect the research projects proposed and approved by US MA. Ensures contracting activities, as applicable, adhere to Internal SOP and WP processes, and Corporate Integrity. Produces final contracts/amendments and secures all necessary company approvals including SOX compliance to facilitate execution of said agreements. Ensures appropriate contractual Amendments and Addendums are in place. Assists US MA CBS team in defining scopes of work (SOW) and preparing project specific milestone payment schedules for both original contracts and amendments.
- ** Collaborator**: ability to collaborate with US Legal and Patent departments to Lead and to answer questions regarding contract terms, scopes of work, pricing, and payment schedules within the framework of the US legal and compliance requirements.
- ** Lead/Manage**:Facilitates/coordinates the process as the lead for NOCC and Evidence Generation and Medical Excellence Associates, inclusive of workload, strategies and priorities by bringing insights from the execution and delivery of tactics.**Manage cross functional reports from Clinical Supply Management, Medical Operations and Contracts and Business Solutions
- ** Excellence in Business Solutions execution**:Coordinates / tracks contract and scope driven milestones and overall CLC and business solutions progress. Provides program management support for selected tactics based on complexity and relevance to harmonize team’s workload and integrate with ED CBS for the overall deliverables. Continuously evaluates to find improvement opportunities and improve strategic and tactical plans.
- ** Budget management**:Ensures FMV and Schedule As abide by US Laws, Regulations and adhere to all local process, aligning milestone deliverables with cost and payment to ensure mínimal deviations from local guidelines and standards. Proactive evaluation and identification of risks/opportunities. Facilitates process to re-prioritize and define mitigative actions.
- ** Stakeholder management & communications**:Engages with multiple stakeholders within Medical Affairs and across the organization to ensure the delivery of quality, timely and cost-effective external resources to support US Medical Affairs. Partners with Executive Director of EGME to lead the process of developing tactical plans aligned to strategies and priorities. Supports projects and initiatives to ensure the workload is prepared to successfully respond to the changing needs and requirements of our business partners.
- ** Knowledge management**:US laws and regulations associated with contract language regarding US Phama regulations to GxP, with specific knowledge of Phase 1-IV, Registries, and IIT studies with secondary knowledge including, but not limited to, research collaborations, MAPS, consultancy agreements and confidentiality agreements, that may shift based on evolving business needs.
- ** Direct Management Responsibility**: Oversee and mentor direct reports, providing guidance, performance feedback, and professional development opportunities to ensure team success.
**Minimum Requirements**:
- Bachelor’s degree in business/legal field required; Advanced degree preferred.
- Minimum 10+ years of experience in the Pharmaceutical Industry and Minimum 7+ years in a Contracting Function.
- Thorough understanding of US clinical trial conduct and regulation.
- Excellent understanding of contracts and financial terms (including legal understanding of terms and conditions).
- Proven record of accomplishments that demonstrate strong contract management, analytical and multitasking skills for business solutions.
- Possess strong internal and/or external influence to achieve business & operational objectives. Excellent interpersonal skills (team player). Proven negotiation skills.
- Demonstrated willingness to make decisions and to take responsibility. Must be able to work independently and be fully agile in adapting to evolving bu
