Novartis
Job Description Summary
Drive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan.
Job Description
職務内容
主な役割責任
必須要件
望ましい要件
Major Accountabilities
· Authoring responsible parts of J-NDAs, response to PMDA and all of the other activities for submission if necessary.
· Assessment of pharmacological and/or toxicological profiles of early projects to contribute to Japan development strategy.
· Roles as JPT/JST members
· Support of TM clinical studies as pharmacologists and/or toxicologists including protocol/ICF review, IB review and interaction with HAs.
· Seeking opportunity of proposals about new development programs/ indications
· Participate/support initiatives, task-forces, and cross-functional activities in Dev./NPKK.
· Quality management responsibility
- Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
- 100% timely delivery of all training requirements including compliance
Key Performance Indicators
· Appropriate quality and timing of NDA and post NDA activities
· Appropriate quality and timing of pharmacological and/or toxicological profiling/evaluation of early projects
· Appropriate quality and timing of study supports
Background
Education: MSc or PhD in life sciences (Pharmacology, toxicology, Pharmaceutics, other specific sciences), DVM/MD or equivalent professional experience.
· Experience/Professional requirement:
· Taking education or possessing knowledge of basic medicine, such as physiology, pharmacology, toxicology, anatomy/histology, molecular biology, etc.
· For mid-carrier employee, experience in pharmacology, toxicology or relevant field of the pharmaceutical Industry, CRO, academia, etc.
English Skill:
Appropriate skills of English (read/write and oral)
Benefits and Rewards
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Additional Information
Be aware of fake job advertisements and job offers. Novartis does not make job offers without interviews and never asks candidates for money. All our current job openings are displayed here. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money, or provide personal information.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Skills Desired
Animal Models, Bioinformatics, Collaboration, Data Analysis, Ethics, Problem Solving, Regulatory Compliance, Toxicology