Senior Manager in Business Consulting Risk at EY focusing on digital risks and risk management strategies for clients. Collaborating with cross - functional teams for effective risk analysis.
About the role
- Medical Governance Lead overseeing governance framework in medical affairs at Novartis. Implementing GxP processes and ensuring compliance with health authority requirements.
Responsibilities
- Ensure the implementation of the established governance framework, health authority requirements, and ICH guidelines for medical GxP activities
- Understand the systems that enables key governance processes in order to give advice and guidance to activity owners, ensuring alignment with risk and quality management practices
- Provide governance support, advice, coaching and expert input to the MA activity owners and teams
- Be the single point of contact for partner functions such as GGO, SSO, QA, Compliance, Safety, CDO (Clinical Disclosure Office), ERC, Procurement and others
- Matter Expert in sponsor and third-party qualification
- Promote local research, ensuring the proper classification of medical activities, in collaboration with the ERC if necessary
- Support data quality/integrity in MA
- Providing insights about value indicators (KPI, KQI) and risks (processes, requirements and L/G regulations)
- Maintain overview and monitor progress of R/C issues, ensure & track escalation, and follow-up until resolution
- Monitoring and giving feedback to improve processes, systems and capabilities, with clear quality and performance metrics
- Track deviation and support implementation/resolution of local CAPA
- Oversee and monitor local audit & inspection readiness and execution, in close collaboration with local QA and Safety Dpt
- Proactively participate in global MGL Network for ensuring continuous improvement, to drive projects and achieve outstanding results
- Support initiatives for creating stronger organizations and a culture of high ethical standards and compliance
- Might lead/co-lead workstream or working group
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
- Possess a strong business strategy acumen to align the medical governance and risk management with organizational goals and objectives
- Strong leadership and strategic skills, with proven experience in driving change, influencing decisions, and fostering a culture of compliance and ethical standards
- Effective problem-solving and collaboration abilities, including risk management, conflict resolution, and a pragmatic, solution-oriented mindset
- Fluent in Spanish and English languages, both in speaking and writing.
Benefits
- Company Pension Plan
- Life and Accidental Insurance
- Meals Allowance or Canteen in the office
- Flexible working hours
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Consultant in Business Consulting Risk at EY focusing on digital risks and consulting strategies in New Delhi.
Analyst in Business Consulting Risk analyzing risks in digital transformation initiatives. Collaborating with teams to develop mitigation strategies and conduct market research in New Delhi.
Analyst role in Business Consulting Risk at EY focusing on data - centric approaches in Consumer Products and Healthcare sectors. Collaborating on risk management and data visualization projects.
Associate Consultant in Business Consulting Risk with EY focusing on internal audit and risk management. Utilizing data analytics and consulting skills across diverse client environments.
Junior Business Risk Analyst working with leading organizations to optimize financial processes. Collaborating with experienced consultants to conduct risk analyses and implement governance frameworks.
Data Governance Officer implementing BCBS239 standards within Operations at Azqore in Lisbon. Leading critical banking operations transformations and ensuring compliance in a dynamic environment.
Senior Framework Manager responsible for data governance and analytics in Santander UK. Driving strategic insights to enhance risk and resilience through innovative data solutions.
ERP security & controls specialist in RSM's Business Application Risk practice. Focused on managing governance and regulatory risk across core business applications with strong IT audit experience.
Supervisor in Government Risk Consulting managing client relationships and supporting risk compliance for public sector programs. Collaborating with agency stakeholders and executing internal control testing across multiple environments.