Senior Medical Governance Manager

Há 1 mês


Santo Amaro, Brasil Healthcare Businesswomen’s Association Tempo inteiro

Job Description Summary

We are looking for a Senior Medical Governance Manager based in São Paulo, to help us implement Real World Evidence (RWE) vision for Novartis to strengthen RWE capabilities in Brazil and further build our efforts to leverage RWE across both early-stage development projects and launch brands.

In this role, you will be responsible for bringing strategic/operational efficiency and robust, accelerated decision-making at the country level, within the areas of scope, through active participation in a global medical governance network and the leadership of a team.

Key Responsibilities:

  • Leading implementation of the end-to-end governance of GxP and other regulated medical activities within the Medical Affairs organization in Brazil.
  • Designing and implementing the Vendor & Collaboration Partner Center of Excellence, including orchestration and oversight of proactively identification, qualification and management of evidence-generation vendors and collaboration partners.
  • Delivering quality data and compliance to quality standards, by guaranteeing adherence to prevailing legislation, GCP, GPP, Ethical Committee, SOP requirements and financial standards.
  • Areas of scope include all evidence generation activities and other regulated medical activities within the Medical Affairs organization in Brazil.

Essential Requirements:

  • Extensive and relevant experience in the pharmaceutical industry.
  • Process excellence.
  • Knowledge and understanding of: (1) Both scientific and operational aspects of clinical drug development and Medical Affairs; (2) GCP, ICH, and all applicable laws and regulations.
  • English: fluent spoken & written.

Desirable Requirements:

  • Experience leading people.
  • Clinical Research (trial execution), Project management / Agile methodologies experience.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us

You’ll receive: Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups and virtual self-development tools.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network.

Skills Desired: Budget Management, Clinical Research, Clinical Trial Protocols, Clinical Trials, Coaching, Cross-Functional Teamwork, Data Analysis, Learning Design, Life Science, Risk Management, Risk Monitoring.

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