Director Medical Affairs
hace 3 semanas
**Summary**:**About the Role**:LI-HybridLocation: Mexico City**Major Responsibilities**:- NOCC Leadership and US Medical Affairs Support- Very strong NOCC-based functional leader, with the ability to influence senior leaders in Novartis- Maintain frequent and clear communication and alignment with US-based Launch Machine leadership, e.g. Head of Launch Machine, Content Development, and Medical Review Heads.- Establish robust local processes, team structures, and performance management systems - including troubleshooting and performance improvement.- Develop and meet operational KPIs to contribute to overall USMA success and high performance of associates and teams.- Proactively address delivery risks, take action on quality issues to ensure proper associate training or immediate intervention to course correct, and execute mitigation plans and status.- Escalate critical issues in real-time and drive efficient resolution.- Lead initiatives to increase efficiency, operational excellence, assess risks and development of risk mitigation plans.- Ensure timely, high-quality, and compliant delivery of Launch Machine outputs and services as defined by Launch Machine leadership.- Develop and present (verbal and written) executive-level reports and dashboards for local NOCC and US leadership.- Represent Mexico Launch Machine Operations in senior forums and contribute to business operations planning.- Contribute to USMA Business Planning as it relates to NOCC Operations.- Contribute to cross-NoCC alignment and harmonize ways of working.- Operational People Management- Build Teams and foster an inclusive culture of collaboration, innovation, and continuous improvement.- Hire, onboard, train, and build Launch Machine local team and capabilities, in alignment with Head Launch Machine, in Mexico.- Align with Head Launch Machine and other US Heads as applicable (e.g. Head Content Development, Head Content Review, MST Heads) in objective setting, performance appraisal, and development planning for local NOCC team.- Manage performance including acquiring Novartis leader feedback to give specific associate insights on where performance meets standards or requires action to correct. Manage corrective actions or termination in accordance with company policy and in compliance with local regulations as necessary.- This role will oversee approximately 10-45 associates in Hyderabad, with potential to grow and develop the team over time, based on business needs. This role will report directly to the Head of Launch Machine in the US.**Content Development**- Lead and oversee local support for Content development and Content operations capabilities. Align with US-based Medical Communications SPOC to establish priorities.- Lead and oversee local execution of content creation support (e.g. trial cards, infographics, speaker programs materials, 3rd party medical education, congress materials and QR Guides (QRGs)).- Support operational efficiencies and quality improvement subsequent to process excellence activities and process support- Budget management (e.g., task orders, purchase orders, monthly forecasts against annual budget plans)- Manage team capacity, including up to weekly reprioritization, in alignment with Head Content Development and/or US-based Medical Communication SPOCs, depending on dynamic content volume and urgent needs- Participate in exploration of AI/Automation opportunities across content development to optimize end-to-end content processes.- Resource Management- Lead and oversee local Resource Management function.- Ensure budget management understanding with all budget owners and influence adherence to defined financial KPls.- Partner with functions across USMA to identify risks/opportunities on an ongoing basis and provide recommendations for reallocation of funds.- Oversee month-end closing process and ensure compliance with SOX, GAP, and NPC policies. Ensure that all projects and forecasts are entered into the appropriate Financial Systems with verification of accuracy of entry.- Regulatory Submission- Oversee Submission Specialist team and execution of US Regulatory Submission processes- Minimum Requirements:- 8-10+ years previous work in Multinational Pharmaceutical Corporation or equivalent highly regulated environments.- Significant experience leading end-to-end Content Development, Medical Review, or Regulatory Submission processes.- Inspiring leader capable of fostering a sense of belonging. Ability to lead in environments with direct and indirect authority.- Proven track record leading cross-functional teams and business planning in matrixed and multicultural settings. Experience working in remote relationships (on-shore/off-shore capability delivery).- Experience managing complex programs and processes in a dynamic environment - scoping, defining deliverables, business case development and reporting at a senior level including the ability to communicate effecti
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