Medical Affairs Excellence Manager

Medical Affairs Excellence Manager
As part of Novartis you are committed to helping realizing your potential and being part of a remarkable employee community. You will work with talented individuals - experts in their field - and be inspired by some of the best leaders in the industry. This is a role waiting for you to put your own stamp on it.

Your responsibilities will include, but are not limited to:
• Establish processes and oversee all local clinical studies such as IITs, NIS (non-interventional studies), MAPs and local clinical trials to ensure, together with the Therapeutic Area Heads, the execution in a timely manner and quality in according to OBU governance, local law and regulations, SOPs, WPs and P3.
• Support the Medical Projects leads in Setup and execution of IITs, NIS, MAPs and Grants while acting as Champion for the above mentioned activities to guarantee an Compliance conform and consistend execution of Medical projects. Ensure clinical operational support and expertise in collaboration with the Therapeutic Area Heads/Medical advisors/MSLs to ensure local IITs are implemented in a timely manner according to the current guidance.
• Implement and secure operational support to local NVS NIS and registries in collaboration with study leads (MA/MSL) such as: MRC and PRC approval via GMA express, contract negotiation and execution, selection of vendor and CRO process and ensure the CSRs (Clinical Study Reports) are compiled in accordance to Novartis SOPs and financial management including phasing.
• Perform accurate tracking of Novartis sponsored local studies, IITs and MAPs in required databases and registries. Point of contact in local (JCMC) and region (WEC/RE) meetings/task forces to support continuous improvement in harmonization of processes across the Swiss Medical Organization, maintaining peculiarities and specific needs for the different medical line units, when needed, always with respect of compliance of medical processes.
• Provides guidance on training requirements in relation to medical processes including SOP’s and written guidance documentation for medical Affairs associates and track that trainings are performed. Act as the go to person for all Oncology Swiss Medical Affairs members.
• Upgrades capabilities in Medical in close cooperation with the Head Business Excellence and the BF Heads including business/competitor intelligence, market data collection and analysis and digital customer engagement.
• Responsible for audit and inspection preparation related to the Country Medical Affairs Team, by creating and setting up plans as needed, in close collaboration with members of the Swiss Medical Leadership Team and CPO Quality Assurance. Build a close collaboration with local QA.
What you’ll bring to the role:
• Minimum MSc degree in natural science, PhD preferred
• Typically would have more than 3-5 years’ experience in clinical medicine and/or Research. Knowledge of both scientific and operational aspects of clinical drug development.  
• Familiar with respective health authority, GCP and ICH requirement. 
• Strong process excellence skills. Strong communication and trainings skill. 
• Successful development and implementation of innovative programs and processes.
• Fluent in German and English (oral and written), basic knowledge in French desirable.

927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

We are Novartis. Join us and help reimagine medicine.
Novartis Pharma Schweiz AG
Research & Development
Full Time