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

Overview

Location:

Cambridge, MA. The individual will provide scientific and operational support to Study Quality and Compliance group within the Toxicology line function of Preclinical Safety (PCS). Key responsibilities include ensuring training records, CVs, and Job Description s (JDs) for all PCS are maintained and on file, periodic review of departmental SOPs, support of health authority inspections and internal audits, coordination with Archive Records Management (ARM) for GLP and non‑GLP study records transfers, and support of SEND package creation and QC.

• Oversee periodic review and maintenance of PCS SOPs, gathering stakeholder input.
• Ensure PCS compliance with training records, CVs, and JDs consistent with GLP requirements.
• Support ARM function by collating listings of archived studies and coordinating transfers to permanent locations.
• Support SEND package creation and quality review for FDA submissions.
• Track and manage study‑related information across various work streams or initiatives.

• Degree in biological related sciences.
• 8+ years of relevant experience in a pharmaceutical setting.
• Experience working in a GLP setting, with general regulatory compliance and animal welfare knowledge related to toxicology studies.
• Good communication skills and excellent logistical/planning skills.
• Fluent in English (spoken and written).

• Previous experience with SEND packages.
• Experience with software for online information and program management.

• Salary range:
  Principal Scientist I: $119,700–$222,300 per year;
  Principal Scientist II: $126,000–$234,000 per year.
• Performance‑based cash incentive and eligibility for annual equity awards.
• Comprehensive benefits package including health, life, and disability benefits, 401(k) with company match, and generous time‑off package (vacation, personal days, holidays, and other leaves).

This is a dual level posting. The final level and title of the offer will be determined by the hiring team based on the skills, experience, and capabilities required to perform the role.

The final salary offered is determined based on 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.