Preclinical Safety Data and Sample Management Expert

Novartis; Cambridge (MA); On-site; USD 73,000 - 137,000; Full time

Job summary

A leading pharmaceutical company is seeking a Preclinical Safety Data and Sample Management Expert in Cambridge, MA. This entry-level role involves managing non-clinical study data, ensuring compliance with FDA and SEND requirements, and advising on data needs for M&As. Candidates should have a Bachelor's degree in a science-related field and expertise in SEND regulations.

Benefits

Bonuses

Stock units

Comprehensive health plans

Retirement plans

Qualifications

• Bachelor’s degree in a science-related field required.
• Expertise in SEND regulations and experience with SEND data is essential.
• Knowledge of GLP policies and non-clinical safety data is crucial.

Responsibilities

• Manage non-clinical study data and samples for M&As.
• Create and QC SEND packages, ensuring compliance.
• Collaborate with CROs and internal teams.

Skills

Expertise in SEND regulations

Knowledge of non-clinical safety data

GLP policies

Education

Bachelor’s degree in a science-related field

Tools

Pristima/Savante

Pinnacle21

SAS XPT/CSV files

Job description

Preclinical Safety Data and Sample Management Expert

Join to apply for the Preclinical Safety Data and Sample Management Expert role at Novartis.

Job Summary

This position is based in Cambridge, MA, with working hours defined by the hiring manager. No travel is required. The expert will manage non-clinical study data and samples related to mergers and acquisitions, ensuring compliance with FDA and SEND requirements. Responsibilities include creating and QC'ing SEND packages, converting data formats, and maintaining proper archiving of safety data and samples. The role also involves advising on data requirements for FDA submissions, collaborating with internal and external stakeholders, and staying updated on regulatory changes.

Key Responsibilities

• Advising on non-clinical data requirements for M&As
• Preparing submission-ready SEND packages
• Transferring SEND data into internal data warehouses
• Overseeing sample and specimen lifecycle management
• Collaborating with CROs and internal teams
• Providing insights and strategic recommendations
• Ensuring policy compliance and regulatory adherence

Essential Requirements

• Bachelor’s degree in a science-related field
• Expertise in SEND regulations and experience with SEND data
• Knowledge of non-clinical safety data and GLP policies

Desirable Requirements

• Experience with Pristima/Savante, Pinnacle21, SAS XPT/CSV files
• Sample tracking experience

Compensation & Benefits

The salary range is $73,500 to $136,500 annually, with additional benefits including bonuses, stock units, and comprehensive health and retirement plans. Final compensation depends on experience, location, and other factors. Visa sponsorship is not available.

Why Join Novartis?

Contribute to innovative healthcare solutions with a passionate community. Learn more at our culture page.

Additional Information

Interested candidates can join the talent community at our talent network for future opportunities. Novartis is an equal opportunity employer committed to diversity and inclusion. Reasonable accommodations are available for applicants with disabilities.

Job Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industry: Pharmaceutical Manufacturing