Senior Medical Governance Manager

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.

On 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

About the Role

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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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.
If you want to learn more about our benefits, you can access the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

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 here: https://talentnetwork.novartis.com/networ

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
International

Business Unit
Innovative Medicines

Location
Brazil

Site
Santo Amaro

Company / Legal Entity
BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No