Principal Scientist

3 weeks ago

Hyderabad, Telangana, India Thepharmadaily Full time
Job Description

As a Principal Scientist in the Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit, you will oversee non-clinical research activities for multiple projects across various disease areas. You will manage in-vitro screening and in-vivo rodent toxicity studies conducted at our CRO partner sites, ensuring adherence to internal strategy and international standards. This role also involves the development and review of nonclinical submission modules (eCTD module 2.4 and 2.6) and other lifecycle management documents.

Major Accountabilities:

- Develop study protocols and designs in collaboration with CRO study directors and internal SMEs for various toxicity assays.
- Review study protocols, data, and reports for different toxicity studies.
- Ensure studies are conducted, recorded, and reported according to protocols.
- Ensure data quality and presentation for internal and external use.
- Coordinate research activities with functional groups to ensure performance, timeliness, and data integrity.
- Resolve study-related issues and communicate with internal experts and stakeholders.
- Track and ensure timely achievement of key milestones in every study.
- Develop regulatory submission documents such as IB, IND/CTA, NDA/BLA/MAA, and briefing books.
- Ensure compliance with Novartis animal welfare policies, CRO SOPs, expert recommendations, and international regulatory guidelines.
- Assist in implementing nonclinical scientific writing and outsourcing plans.

Essential Requirements:

- Education:PhD in life sciences with 3+ years, MVSc with 8+ years, or MS/M.Pharm with 10+ years of experience in drug discovery/development, safety assessment, and regulatory submission writing.
- Knowledge:In-depth knowledge of toxicology assays, safety pharmacology, and genotoxicity.
- Skills:Proficient in regulatory submission writing, eCTD structure, good documentation practices, and document management systems. Extensive library research skills and problem-solving techniques.
- Experience:Publication and presentation experience preferred.

Desirable Requirements:

- Strong teamwork and logistical/planning abilities.
- Registration and certification with international toxicology registers.
- Strong English writing skills

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