| || Provide state-of-the-art medical and clinical development expertise to drive Novartis message de livery to key influencers and stakeholders. Provide input and ensure alignment between global project strategy and local needs to drive Medical Affairs for a brand in the local business franchise.
• Expertise and Medical support: Contribute strategic, medical, clinical and scientific guidance to all allied departments in local CPO, including support the local ICRO team for timely execution of studies conducted in the CPO and to DRA in interactions with authorities.
• Collaboration: Ensure optimal collaboration with CPO, Regional and Global Teams in the execution of relevant clinical activities including initial input in programs strategy and designs of clinical studies.
• Local studies and publication: Oversee design of Post Phase III activities.
• Safety: Ensure proper local clinical trial adverse event reporting together with CS&E as well as clinical oversight into adherence to GCP is provided by TA I BU associates, when applicable.
• Investigators: In collaboration with Clinical Operations (ICRO), recommend potential investigators for local and global studies, ensuring the right mix of KOLs.
• Medical AffairsiMktg: Partner with Marketing to develop and implement C4MPH strategy.
• Customers: Take ownership for meeting customers' needs and expectations for assigned Brand(s), for delivery of Novartis messages to key influencers and stakeholders as the brand champion interface for internal and external customers.
• SciOps: Collaborate with Scientific Operations I Medical Scientific Liaisons proactively to en
sure market preparation pre- and post-launch.
• NP4/Materials: May review promotional and training material tailored to the needs of the product and according to NP4 and local regulations.
• KOLs: Ensure development of network with external experts in collaboration with SciOps and MICS to disseminate clinical data proactively and reinforce clinical awareness with KOLs, influencers and key external customers.
• Image: Promote and maintain ethical standards of CPO Medical Advisors to contribute proactively to a credible image for Novartis CPO in the local Health Care and Medical community.
• COMPULSORY: Associate shall be accountable to perform all duties listed in Role Profile in accordance with applicable GxP principles, and internal/external regulations (e.g. Novartis Code of Conduct, Novartis Pharma Principles and Practices for Professionals (NP4), Rx&D Code of Ethical Practices, Health Canada and all other relevant regulations).
| || • MD, DO or PhD degree in Health Science required, as per CPO strategy and/or local regulations.
• 3-5 years of experience in clinical medicine and/or research with ideally 2-3 years of in Pharma industry.
• Good planning skills as well as medical and scientific writing skills.
• Knowledge of assigned therapeutic area and scientific expertise with ability to interact with relevant KOLs as a peer.
• Knowledge of all aspects of drug development, GCP and local regulations, including regulations of Promotional materials. Familiar with global regulations.
• Ability to analyze and interpret results, ability to present scientific data to scientific and lay audiences.
• Knowledge of clinical trial design statistics and pharmacokinetics.
• Understanding of marketing principles and strategies.
• Bilingualism- Oral and Written: English and French (Quebec only).