Principal Scientist - Toxicology at Novartis

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Animal Models, Bioinformatics, Collaboration, Communication Skills, Data Analysis, Ethics, Problem Solving, Regulatory Compliance, Researching, Risk Assessments, Toxicology, GLP, SEND Packages, SOP Maintenance, Quality Checks, Electronic Laboratory Notebooks

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary This role will provide scientific and operational support to Study Quality and Compliance group within PreClinical Safety (PCS) function. Job Description Major Accountabilities: Ensuring PCS compliance with training records, CV, and JDs. Ensure all documentation is consistent with GLP requirements. Support periodic review and maintenance of PCS SOPs. Maintain good working knowledge of any company SOPs that influence or impact the PCS SOPs. Get necessary input/feedback from relevant stakeholders to keep documentations up-to-date· Create and perform quality checks on SEND packages for FDA submissions Support electronic laboratory notebook compliance ensuring the necessary reviews and compliance with company guidelines Support the Study Quality and Compliance team’s effort for tracking and managing study-related information in a global online fashion by leveraging the use of software tools to enhance productivity and information sharing. Minimum Requirements: Graduate/ Postgraduate in Life Sciences with 10-15 years relevant experience working in pharmaceutical GLP setting. Good working knowledge of regulatory compliance requirements Knowledge of animal welfare requirements related to study conduct Previous experience creating and reviewing SEND packages Good communication skills, and excellent logistical/planning skills Previous experience with software for online information and program management is a plus Skills Desired Animal Models, Bioinformatics, Collaboration, Communication Skills (Inactive), Data Analysis, Ethics, Laboratory (Inactive), Problem Solving, Regulatory Compliance, Researching, Risk Assessments, Toxicology Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. 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 personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Provide scientific and operational support to the Study Quality and Compliance group within PreClinical Safety. Ensure compliance with GLP requirements, maintain SOPs, and manage SEND packages for FDA submissions.