Boehringer Ingelheim
Senior Principal Scientist Ocular Drug Delivery/IVT(m/w/x)
Full-timeOn-siteManagement
Biberach
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Expert input and strategy for clinical development initiatives and products, leading risk management teams. Medical Degree and 5 years drug development experience required. International collaboration across diverse multinational teams.
Requirements
- Medical Degree or equivalent
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development
- Experience in clinical trial methodology and regulatory requirements
- Expertise in clinical safety assessments and regulatory submissions
- Experience with issue management
- Experience in leading cross-functional teams
- Fluent English (both spoken and written)
- Additional languages are an advantage
- Experience in Clinical Research and Clinical Trials
- Experience in Leadership and Medical Strategy
Tasks
- Provide expert safety input for clinical development programs
- Participate in the Global Program Team, Global Clinical Team, and Clinical Trial Team
- Lead the Safety Management Team
- Manage safety issues throughout the project lifecycle
- Own the safety strategy for projects and products
- Produce medical safety deliverables
- Develop and maintain safety information in the Core Data Sheet
- Address safety issues across all project and product indications
- Oversee signal detection and monitoring of safety information
- Evaluate and interpret safety data from relevant sources
- Prepare safety strategies for health authority responses
- Collaborate with project team members on safety inquiries
- Respond to regulatory authorities and healthcare professionals regarding safety issues
- Contribute to departmental and functional goals and objectives
- Engage in developing competencies within the Medical Safety Function
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Expert input and strategy for clinical development initiatives and products, leading risk management teams. Medical Degree and 5 years drug development experience required. International collaboration across diverse multinational teams.
Requirements
- Medical Degree or equivalent
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development
- Experience in clinical trial methodology and regulatory requirements
- Expertise in clinical safety assessments and regulatory submissions
- Experience with issue management
- Experience in leading cross-functional teams
- Fluent English (both spoken and written)
- Additional languages are an advantage
- Experience in Clinical Research and Clinical Trials
- Experience in Leadership and Medical Strategy
Tasks
- Provide expert safety input for clinical development programs
- Participate in the Global Program Team, Global Clinical Team, and Clinical Trial Team
- Lead the Safety Management Team
- Manage safety issues throughout the project lifecycle
- Own the safety strategy for projects and products
- Produce medical safety deliverables
- Develop and maintain safety information in the Core Data Sheet
- Address safety issues across all project and product indications
- Oversee signal detection and monitoring of safety information
- Evaluate and interpret safety data from relevant sources
- Prepare safety strategies for health authority responses
- Collaborate with project team members on safety inquiries
- Respond to regulatory authorities and healthcare professionals regarding safety issues
- Contribute to departmental and functional goals and objectives
- Engage in developing competencies within the Medical Safety Function
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Novartis
Industry
Pharmaceuticals
Description
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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