Novartis Group Companies

Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology

Cambridge (USA) · Principal

Sponsorship not specifiedDetected 13 days ago

Data AnalysisComputer VisionComplianceFDA RegulatoryBioinformaticsResearchAnimal StudiesAnimal ModelsCommunicationCollaborationProblem Solving

About the role

Key areas of responsibility or oversight include ensuring training records, CVs, Job Descriptions (JDs) for all of PCS are appropriately maintained and on file, as well as periodic review and maintenance of departmental SOPs.
This person will also be responsible for coordinating with the Archive Records Management function for the transfer of GLP and non-GLP study records and materials from one archive location to another.
The salary for this position is expected to range between: Principal Scientist I: $119,700 and $222,300 per year.

Support SEND package creation and quality review for FDA submissions
Support the Study Quality and Compliance team's effort for tracking and managing study-related information through input of information types from the areas of responsibility above and generally support the effort in various workstreams or initiatives.
The individual will provide scientific and operational support to Study Quality and Compliance group within the Toxicology line function of Preclinical Safety (PCS).

Degree in biological related sciences
8+ years of relevant experience working in a pharmaceutical setting
Experience working in GLP setting, and general regulatory compliance and animal welfare knowledge related to conduct of toxicology studies
Previous experience with SEND packages is desirable
The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.
The ideal candidate would also have experience with SEND (Standard for Exchange of Nonclinical Data) packages to provide support for both creation and QC of these datasets.

Previous experience with software for online information and program management is a plus

$119,700.00 - $222,300.00
$119,700 and $222,300 per year.
The salary for this position is expected to range between:
Principal Scientist II: $126,000 and $234,000 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.
Novartis may change the published salary range based on company and market factors.
$126,000 and $234,000 per year.

With respect to these items, provide support to health authority inspections and internal inspection-readiness audits.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.

We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

The Novartis Group of Companies are Equal Opportunity Employers.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
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