Internship role at Emerson in Cluj - Napoca, Romania, focused on governance and securities responsibilities. Engaging with a diverse team to drive innovation and foster a collaborative environment.
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
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