Risk Management Lead Associate Director

Há 7 horas

São Paulo, São Paulo, Brasil Beigene Tempo inteiro
Job Title: Risk Management Lead Associate Director

BeiGene is a rapidly growing company with exciting opportunities for experienced professionals. We are seeking a highly motivated and collaborative Risk Management Lead Associate Director to join our team.

Key Responsibilities:
  • Provide onboarding training and tools to assigned teams to aid in the adoption of Risk-Based Quality Management (RBQM).
  • Facilitate risk management with stakeholders to identify critical to quality factors and manage risks.
  • Collaborate with cross-functional teams to analyze risks and issues using quality performance data.
  • Draft, maintain, and archive risk management documentation using RBQM tools and following BeiGene SOPs.
  • Trend risks and issues across related entities.
  • Support the study team in optimizing controls applied based on risk evaluation.
  • Develop and lead culture change and communication activities with stakeholders.
  • Conduct ad hoc risk assessments as needed to support clinical development.
Requirements:
  • 8+ years of experience leading risk assessments in the pharmaceutical industry or equivalent.
  • Prior experience deploying risk-based quality management programs across clinical development preferred.
  • Ability to work independently to complete management and oversight activities.
  • Experience working and communicating within cross-functional teams.
  • Knowledge of overall clinical trial management process, understanding of the protocol and other clinical trial related plans and documents.
  • Critical thinking and analytical skills to understand and analyze complex data.
  • Therapeutic area specific experience and knowledge – Oncology/Hematology preferred.
  • Ability to use relevant technology and risk-based tools/platforms effectively.
  • Proven track record in delivering agreed results against a plan and timeline.
  • Understanding of ICH and regulatory environment.
  • Problem-solving skills.
  • Self-management skills.
  • Ability to work in a global team environment.
Travel:

0-20% travel required.

BeiGene is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

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