Compliance & Governance Training Lead (Oncology Medical Affairs) (m/f/d)

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  • August 2021
  • nicht angegeben
  • CH-Basel
  • auf Anfrage
  • 22.07.2021
  • 556434/1-en

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Projektbeschreibung

Ihre Aufgaben:
• Lead design and implementation of “Just-In-Time (JIT)” training concept for Oncology Medical Affairs (OMA)
• Operate and monitor execution of JIT training
• Advise Pharma Medical Affairs on JIT training implementation
• Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring) 
• Provide ad-hoc support to key projects (namely GEMS rollout, HCP Experience)

Ihre Qualifikationen:
• Scientific qualification (PhD, MSc or Bachelor’s Degree) in in an appropriate scientific discipline or quality-related field with an in-depth knowledge of the international pharmaceutical product development process
• Must have is Pharma experience; FDA knowledge is an advantage
• Familiar with Quality management, Risk management, documentations in a compliant way, should be hands-on
• Profound experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities
• Expertise in the principles and practices of Quality Risk management and / or GxP audits
• Strong analytical and planning skills
• Able to understand and work with enterprise and functional systems & data
• Experienced in implementing and deploying projects/ changes in an organization
• A broad understanding of Quality Management, GCP / GVP and Risk Management processes
• A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines
• Proven self-starter with experience in building capabilities based on defined business needs across geography and functions
• Fluent in written and spoken English
• Strong and confident communicator both internally at all levels and externally with outside and industry bodies

Ihre Vorteile:
• Option for extension
• You will work in an international environment 

Projektdauer: 12 MM++

• One of the biggest pharmaceutical companies of the world 



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