Summary
The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist, you will join our PCS team in India to oversee non-clinical research activities for multiple projects across multiple disease areas for in-vitro screening and in-vivo rodent toxicity conducted at our CRO partner sites as per the internal strategy and international standards, acting as the primary scientific contact for the Study Director. This role also involves development and review of nonclinical submission modules (eCTD module 2.4 and 2.6) and other lifecycle management documents for multiple projects based on the deep understanding of every preclinical study report contributing to submission package.
About The Role
Major accountabilities:
- Develop study protocols and study designs in collaboration with CRO study directors and internal SMEs for genotoxicity, phototoxicity, immunotoxicity, cardiotoxicity (ion channel) assays and in-vivo rodent toxicity studies.
- Review study protocols, study data and study reports for different toxicity studies.
- Ensuring that the study is conducted, recorded, and reported according to the study protocol.
- Ensure data quality and presentation for internal and external use.
- Coordinating research activities with functional groups across the organization to ensure performance, timeliness, and integrity of data generated by CRO partners.
- Resolution of study related issues, liaisons with internal experts, and communicating with appropriate people in a timely manner is pivotal to the performance of this role.
- Tracking and ensuring timely achievement of key milestones in every study of every program at the CRO will be an important KPI for this role including tracking study phases, sample transfer, etc.
- Work as integral part of nonclinical scientific writing team in developing relevant sections of regulatory submission documents such as IB, IND/CTA, NDA/BLA/MAA and briefing book.
- Ensure that the deliverables and studies are compliant with Novartis animal welfare policies, CRO in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
- Work closely with the local team and help implementation of the nonclinical scientific writing and outsourcing plan.
Essential Requirements
- PhD in life sciences with 3+ years or MVSc with 8+ years or MS/M.Pharm with 10+ years of experiences in drug discovery and/or development, safety assessment, regulatory submission writing
- In-depth knowledge of toxicology assays in early development, Safety pharmacology and genotoxicity
- Proficient in regulatory submission writing with the up-to-date knowledge of eCTD structure, hierarchy, good documentation practices and experience of working with document management system.
- Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred.
Desirable Requirement
- Strong team players and have a high level of logistical/planning ability.
- Registration and certification with one of the International Toxicology registers.
- Strong English writing skills considered a preference.
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
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