Global Medical Affairs Governance, Associate

5 This is the number of Therapeutic Disease Areas in which you will be involved - and you will work with a hugely diverse pool of teams and functions.

The Global Medical Affairs Governance, Associate Director will support the creation and implementation of an integrated Global, Regional and Local Governance strategy to ensure adequate oversight and monitoring of Worldwide Franchise (WWF) activities ensuring compliance with GxP and P3 standards and external requirements and laws and in alignment with Global Oncology Medical Affairs.

Your responsibilities will include:

- Provide input or develop and maintain the Novartis standards and frameworks, guidelines and processes across Pharma Medical Affairs and periodically review based on changes of applicable laws, codes or Novartis strategy; support cross functional as well as cross divisional alignment.
- As the point of contact for Global Functions, Regions and CPOs act as a professional advisor to the WWF, ensuring that the programs and engagements contribute to the organization's mission and priorities.
- Drive creation of novel solutions, consistent process rollout and implement training in line with the portfolio strategy and provide input to global initiatives to address internal and external issues that affect the organization across Franchises, regions and countries.
- Supports global franchise teams in the development, tracking and monitoring of robust CAPAs arising from self-identified deviations, affiliate audits and inspections.
- Defines and monitors risk, quality and compliance objectives in alignment with GMA global strategy and Novartis Global Quality Plan at the global, regional and local level.
- Supports change management to promote a sustainable culture and attitude of high ethical standards and adherence to process across the global franchise teams, region and countries and embed it into daily work.
- Be responsible and provide high quality input for compliance reporting and its business process for the global and country organization covering GxP areas
- Represent GMA at relevant boards

**Commitment to Diversity & Inclusion**:

- 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:
Essential:

- In-depth knowledge of pharmaceutical compliance and corporate governance principles, a minimum of 5 years’ relevant experience in the pharmaceutical industry within a GxP environment
- You will have a focus in either data generation vs data dissemination or GxP vs Healthcare Compliance but should also have a good understanding of the other area
- Excellent communication, collaboration, interpersonal and presentation skills, Outstanding problem-solving abilities.
- Thorough knowledge of market changes and forces that influence the company
- 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.

Desirable:

- Previous experience in a country/ Regional role.
- Expertise in successfully leading cross functional, cross cultural teams, projects and process improvements in a complex environment and to demonstrate measurable improvements in performance.
- Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies.

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

Join our Novartis Network:
**Division**

PHARMA

**Business Unit**

GLOBAL MEDICAL AFFAIRS

**Country**

Switzerland

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Marketing

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No