Job Description
Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!Independent clinical assessment of products, including complex, offered by partner companies to verify compliance with internal quality standards, GxP and regulatory guidelines within global due diligence (DD) and business development (BD) teams, and continuous clinical support throughout the BD project execution phase.
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Evaluate appropriateness of clinical development programs or dossiers offered by partner companies (due diligence = DD): evaluate and review available clinical data (including bioanalytical data, in-vitro studies and dissolution data), prepare dossier assessment summaries for BD and regulatory team including project related risks and proposed risk mitigation strategies
Provide scientific and regulatory advice to BD and partner companies as needed to correct the gaps or minimize the risks identified
Provide inputs to BD with budget planning and contract negotiations for in-licensing deals
Collaborate and interface with BD and regulatory teams to support responses on deficiency letters during regulatory procedures
Develop clinical strategies for countries in scope and keep overview of ongoing and planned clinical activities
Support local clinical teams with scientific inputs and guidance for execution of clinical studies for BD products
Collaboration with wider clinical development community. Collaboration on global clinical initiatives. Responsibility for personal and professional development
Other tasks determined during the annual objectives setting process and by KPIs. Other tasks as assigned by the supervisor, and tasks based on a specific appointment
What you’ll bring to the role:
Essential Requirements:
Qualification: University degree (BSc) in pharmacy, medicine or other related natural science
Languages: Fluent in English;
Knowledge of Microsoft Office
Work Experience: 3 years of experience in clinical development or associated fields
Language:
English.
Skills Desired
Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis