Medical Governance Lead at Novartis ensuring compliance and excellence in medical governance within the pharmaceutical industry. Leading cross-functional teams and overseeing governance framework implementation.
Responsibilities
Ensure the implementation of the established governance framework.
Understand the systems that enable key governance processes.
Provide governance support, advice, coaching and expert input to the MA activity owners and teams.
Be the single point of contact for partner functions.
Promote local research, ensuring the proper classification of medical activities.
Support data quality/integrity in MA.
Maintain overview and monitor progress of R/C issues.
Track deviation and support implementation/resolution of local CAPA.
Oversee and monitor local audit & inspection readiness and execution.
Proactively participate in global MGL Network for ensuring continuous improvement.
Requirements
Bachelor's scientific degree, PhD or equivalent in a relevant field (e.g., Medical Sciences, Life Sciences, Medicine or related fields)
Minimum of 5 years of experience in the pharmaceutical industry, preferably in medical affairs, clinical development, medical compliance/Governance, quality assurance, risk management, regulatory, or a related area.
Strong knowledge of GxP processes and medical guidelines.
Deep understanding of health authority requirements and ICH guidelines.
Experience in self-assessments, audits, and managing CAPA.
Experience in working with global teams and cross-functional collaboration.
Demonstrated capability to work across functions.
Strong business strategy acumen.
Strong leadership and strategic skills.
Effective problem-solving and collaboration abilities.
Fluent in Spanish and English languages, both in speaking and writing.
Risk Decision Model Development - Assistant Vice President at Citi using Machine Learning techniques for Account Management Risk Models. Collaborating on model compliance and delivery with various teams.
Responsible for tax compliance and governance at Tigre, ensuring integrity across corporate systems. Managing audits, training staff, and updating tax rules within SAP and Tax One.
Corporate Governance Assessor at Sicredi, interacting with management and stakeholders. Responsibilities include organizing meetings, drafting minutes, and ensuring compliance with governance practices.
Senior leader within the First Line Risk & Control Office overseeing the Issue Management Program. Responsible for driving proactive risk management and governance across the firm.
Independent Panel Member providing oversight on governance, risk management, and compliance at the UK Civil Aviation Authority. Engaging with audit activities and supporting risk frameworks.
Data Risk Management Director managing data risk governance, reporting, and compliance for Early Warning Services. Collaborating with various departments to ensure data risk alignment and oversight.
Analyst optimizing fraud risk strategies for financial services at Early Warning. Collaborating with stakeholders to develop and implement fraud risk management strategies.
Senior Manager overseeing ORM Governance and Practices at Early Warning Services. Leading risk management frameworks and operational risk reporting for financial services.
Director leading Data Operations and Governance at Nuveen's India office. Managing data stewardship practices and aligning governance initiatives for global asset management operations.