343125BR
Apr 05, 2022
China

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
· Act POP Champion for local associates involved in POPs; provide advice and guidance
· Ensure that the local POP governance is aligned with the Global Governance Office (GGO) and POPs managed by the country organization meet patient safety and compliance requirements
· Monitor and maintain the Novartis POP standards, policies, guidelines and procedures according to applicable laws and regulations for the respective country organization (or cluster of countries)
· Implement POP local controls matrix and perform country self-assessments
· Support the development of training for associates and management to ensure adherence to standards
· Regularly interact with GGO and other country organizations via POP champion forums, Governance Boards, and virtual or face-to-face meetings, to continuously enhance the Novartis POP standards and to share best practices
· Ensure effective communication with Novartis teams; present to Novartis Management as requested (e.g. Governance Boards, Leadership Teams, etc.)
· Proactively identify quality and compliance risks related to POPs and establish mechanisms to mitigate these risks in collaboration with Legal, Compliance, Quality Assurance and the Novartis Chief Medical Office and Patient Safety (CMO&PS) organization
· Support inspection and audit preparation for health authority inspections, quality audits and internal audits
· Collaborate with country organizations to set-up and execute appropriate corrective and preventive actions plans in case of major audit or inspection findings
· Escalate issues to the local CMO&PS leadership, the GGO and local senior management (e.g. CSOs, Medical Directors, Commercial Heads)
· Drive change management initiatives and promote a culture of quality, compliance and patient centricity
· Participate in cross-functional Governance Boards, global task forces and project teams, as needed

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
· Master Degree in Science, or equivalent
· Relevant first work experience (ideally 3 years) in the pharmaceutical industry or public health sector, in the area of medical affairs / medical practice, drug development, quality assurance, patient safety or compliance
· Good technical knowledge in relevant governance area
· First experience in working in matrix teams and larger project teams
· High learning agility, comfortable with complexity and diversity, and highly interested in continuous improvement
· Very good communication skills. Very good interpersonal skills demonstrating the Novartis values for collaboration, quality and integrity
· Ability to interact with internal and external customers. Openness to change and ability to promote a cultural of high ethical standards and compliance

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s 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, follow us via Novartis Group WeChat Recruitment Account.

Global Drug Development
CMO & PATIENT SAFETY GDD
China
Beijing
Research & Development
Full Time
Regular
No
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343125BR

POP Governance Specialist

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