Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology
Novartis
August 21, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Oversee periodic review and maintenance of PCS SOPs, obtaining stakeholder input and maintaining working knowledge of relevant company SOPs.
- Ensure PCS compliance with training records, CVs, and Job Descriptions (JDs) consistent with GLP requirements.
- Support Archives Record Management (ARM) by collating listings of studies with records/materials archived at CRO study sites and coordinating ARM transfers to permanent archive locations.
- Support SEND package creation and quality review for FDA submissions.
- Support Study Quality and Compliance tracking/management of study-related information and contribute to workstreams/initiatives.
Essential Requirements:
- Degree in biological related sciences.
- 8+ years of relevant experience working in a pharmaceutical setting.
- Experience in GLP settings with regulatory compliance and animal welfare knowledge for toxicology study conduct.
- Good communication skills; excellent logistical/planning skills.
- Fluent in English (spoken and written).
Desirable Requirements:
- Previous experience with SEND packages.
- Experience with software for online information and program management.
Benefits (explicitly stated):
- Comprehensive benefits package (health, life, disability), 401(k) with company contribution/match, and time off (vacation, personal days, holidays, other leaves).
Application Instructions:
- If you need a reasonable accommodation for the application process, email [email protected] or call +1(877)395-2339; include the job requisition number.
- Oversee periodic review and maintenance of PCS SOPs, obtaining stakeholder input and maintaining working knowledge of relevant company SOPs.
- Ensure PCS compliance with training records, CVs, and Job Descriptions (JDs) consistent with GLP requirements.
- Support Archives Record Management (ARM) by collating listings of studies with records/materials archived at CRO study sites and coordinating ARM transfers to permanent archive locations.
- Support SEND package creation and quality review for FDA submissions.
- Support Study Quality and Compliance tracking/management of study-related information and contribute to workstreams/initiatives.
Essential Requirements:
- Degree in biological related sciences.
- 8+ years of relevant experience working in a pharmaceutical setting.
- Experience in GLP settings with regulatory compliance and animal welfare knowledge for toxicology study conduct.
- Good communication skills; excellent logistical/planning skills.
- Fluent in English (spoken and written).
Desirable Requirements:
- Previous experience with SEND packages.
- Experience with software for online information and program management.
Benefits (explicitly stated):
- Comprehensive benefits package (health, life, disability), 401(k) with company contribution/match, and time off (vacation, personal days, holidays, other leaves).
Application Instructions:
- If you need a reasonable accommodation for the application process, email [email protected] or call +1(877)395-2339; include the job requisition number.