Job Description
Have you ever imagined how does your work impacts society and how many lives can you improve through your daily activities?
- Provide medical expertise, lead and perform protocol, country and site feasibility. Provide consolidated feasibility and site selection input to global teams.
- Provide protocol, Risk management plan & disease training as appropriate at Investigator’s Meetings or scientific venues or internally.
- Review and try to resolve local medical issues / questions that arise during the entire course of the study – if necessary transferring issues to global teams.
- Perform local AE review and provide general medical support for safety issues.
Provide medical expertise support to pharmacovigilance activities.
- Be aware of clinical trial SAEs on a country level o Follow-up with the Investigator for additional information or clarifications as needed.
- When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc*
- Ensure accuracy of translation of medical information related to clinical trials when translated into the local language, including the patient narrative.
- Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials.
- Support ICRO/ and Global teams in interaction with regional regulatory agencies.
Minimum Requirements
- Medical degree is mandatory.
- Experience in medical practice and fully trained in all aspects of drug development including clinical research, GCP, local regulatory requirements.
- English proficiency advanced is mandatory.
- Ability to manage a study from the medical perspective, and a demonstrated capability to problem solve and mediate complex medical / operational issues within the regional and therapeutic area context.
- 2-3 Years pharmaceutical industry experience desirable.
- Demonstrates a knowledge of how to ade-quately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
- Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
- Ability to assess the feasibility of implementing the protocol based on regional medical practice.
- Demonstrates a high level of understanding of the protocol to train others on the protocol including
Why consider Novartis Group of Companies?
750 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Division
Global Drug Development
Business Unit
CD&A; GDD
Country
Argentina
Work Location
Buenos Aires
Company/Legal Entity
Novartis Argentina S.A
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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