Principal Scientist

3-8 years

Not Disclosed

Hyderabad

12 May 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company: Novartis Healthcare Private Limited

Division: Biomedical Research

Business Unit: Pharma Research

Location: Hyderabad, India

Site: IN10 (FCRS = IN010)

Functional Area: Research & Development

Job Type: Full-time

Employment Type: Regular

Shift Work: No

About Novartis:

Novartis is dedicated to reimagining medicine to improve and extend people’s lives. Our vision is to become the most valued and trusted medicines company in the world. Our mission is driven by our associates who strive daily to achieve our ambitions. Learn more about our culture and values here.

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. Novartis offers a diverse and inclusive workplace where all employees feel valued and respected.

Join Our Network:

If this role does not suit your experience or career goals but you want to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here.

Position: Principal Scientist, Preclinical Safety (PCS)

About the Role:

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.

Why Novartis:

In 2020, Novartis medicines touched 769 million lives. We believe that new insights, perspectives, and groundbreaking solutions can be found at the intersection of medical science and digital innovation. Join us to collaborate with courage and ambition, tackling the world’s toughest medical challenges.

Learn More:

Discover more about our benefits and rewards in the Novartis Life Handbook here.

Join Our Network:

If this role is not suitable for you but you wish to stay connected to hear more about career opportunities at Novartis, join our talent community here.

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Principal Scientist

Job Description

About Novartis:

Position: Principal Scientist, Preclinical Safety (PCS)

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