POP Governance Manager

Major Accountabilities

• Responsible for the full implementation of the Local POP Governance Framework which enables the end-to-end POP process, embeds Medical, Quality, Patient Safety, Regulatory, Ethical, Risk and Compliance requirements and facilitates cross functional stakeholder involvement.  at the same time, ensuring alignment with local laws and regulations.
• Provide guidance and support for local associates involved in POPs throughout the program lifecycle; Develop and deliver training for local associates and management to ensure standards are well understood and followed by all associates.
• Manage and oversee all Governance and POP monitoring activities at country organization or assigned cluster of countries.
• Lead the Local POP Governance Board or equivalent body ensuring timely and comprehensive review of programs and POP related issues.
• Proactively identify quality and compliance risks, establish mechanisms to mitigate these risks in collaboration with risk experts and Implement controls to measure compliance; review audit outcomes and perform country self-assessments as needed. Escalate issues if necessary to the Global POP Governance Office and local senior management.
• Participate in cross-functional initiatives, global task forces and project teams. Act as an integral member of local implementation team, working closely with key stakeholders to drive POP strategy and implementation in the local organisation.
• Support preparation for of health authority inspections, internal audits related to POPs, as needed.
• Be an ambassador for the Novartis values and behaviours and support the journey towards an inspired, curious, unbossed and self-aware organization.
• Establish and maintain effective communication channels with global and local teams and senior leaders at Novartis, to continuously enhance the Novartis POP standards and share best practices.
• Support the Global Governance Office in the development and implementation of the Novartis POP standards, policies, guidelines, and procedures.

Key Performance Indicators

• POP standards are implemented locally, and POPs are executed in a compliant way; potential risks are identified and mitigated.
• Health Authority inspections and internal audits have no critical POP findings due to lack of local governance.

Ideal Background

Education:

Master’s degree in science

Doctor of Medicine (M.D.) or Pharm D. is a plus

Languages:

Excellent Mandarin Chinese and English language skills

Experience/Professional Requirement:        

• Relevant work experience (min. 5-8 years) in the pharmaceutical industry or public health sector, in the area of Patient Support and/or Market Research Programs, medical affairs, drug development, patient safety or compliance
• Exemplary interpersonal skills demonstrating the Novartis values for collaboration, quality and integrity.
• Proven track record in leading matrix teams in organizations
• High learning agility, comfortable with complexity and diversity, and highly interested in continuous improvement.
• Excellence in communicating effectively across different audiences and organizational levels; ability to bridge between scientific and business experts.
• Good awareness about regulatory trends and ability to proactively address needs based on external demands.
• Excellence in designing and continuously improving business processes to meet quality and compliance standards and to simplify the way we work.
• Proven ability to build strong and effective relationships with business partners in global organizations.
• Ability to facilitate and influence decision making with local and global senior leaders.
• Change management skills and ability to promote a cultural of high ethical standards and compliance.