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.
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