Preclinical Safety Data and Sample Management Expert

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

Job summary

An established industry player is seeking a Preclinical Safety Data and Sample Management Expert to oversee non-clinical study data related to mergers and acquisitions. This role involves ensuring compliance with FDA submission requirements and managing SEND packages. The ideal candidate will have a strong background in science and experience with SEND regulations, making a significant impact on data management and regulatory compliance in a collaborative environment. Join a forward-thinking company committed to advancing healthcare through innovative research and development.

Benefits

Sign-on bonuses

Stock units

Comprehensive health plans

Retirement plans

Discretionary awards

Qualifications

• Expertise in current and upcoming SEND regulations.
• Experience with SEND data in pharmaceutical or biotech settings.

Responsibilities

• Advising on non-clinical data HA submission requirements.
• Providing submission-ready SEND packages for FDA submissions.

Skills

Animal Models

Bioinformatics

Chemistry

Collaboration

Communication Skills

Data Analysis

Drug Discovery

Ethics

Laboratory

Lifesciences

Medical Research

Patient Care

Pharmaceutics

Physics

Problem Solving

Quality Control

Regulatory Compliance

Research

Risk Assessment

Telemetry

Education

Bachelor's degree in a science-related discipline

Tools

Pristima/Savante

Pinnacle21

SAS XPT/CSV files

Sample tracking systems

Job description

Job Description Summary

About the role:

#LI-Hybrid

This position is based in Cambridge, MA. The working hours will be defined by the hiring manager. No travel is required for this role.

The Preclinical Safety Data and Sample Management Expert will manage all non-clinical study data and samples related to mergers and acquisitions (M&As). The candidate should understand non-clinical safety data requirements for FDA submissions and advise during due diligences. Responsibilities include creating and QC'ing SEND packages, converting data into SEND format, integrating data into internal warehouses, and ensuring proper archiving of data and samples. Knowledge of current SEND requirements and strong communication skills are essential, along with keeping abreast of future regulatory changes. The role may also involve participating in external consortia to shape industry policy.

Job Description

Key Responsibilities:

1. Advising during M&As on non-clinical data HA submission requirements.
2. Providing submission-ready SEND packages for FDA submissions.
3. Transferring SEND data into Novartis' data warehouse and overseeing the lifecycle of vendor samples and specimens to ensure proper archiving.
4. Creating and assessing the quality of SEND packages in collaboration with CROs.
5. Collaborating with internal and external partners.
6. Offering strategic recommendations and insights to leadership.
7. Building cross-functional relationships to align with business objectives and understand key brands.
8. Ensuring compliance with all relevant policies, laws, and regulations.

Essential Requirements:

• Bachelor's degree in a science-related discipline.
• Expertise in current and upcoming SEND regulations.
• Experience with SEND data in pharmaceutical, biotech, or life sciences settings.
• Knowledge of non-clinical safety data and sample retention policies in line with GLP regulations.

Desirable Requirements:

• Experience with Pristima/Savante, Pinnacle21, and SAS XPT/CSV files.
• Experience with sample tracking systems.

Compensation and Benefits: The starting salary range is $73,500 to $136,500 annually, with potential adjustments based on market conditions, experience, and location. Benefits include possible sign-on bonuses, stock units, discretionary awards, and comprehensive health and retirement plans. Details will be provided upon offer. The position is at-will, and the company reserves the right to modify compensation.

Note: Visa sponsorship is not available for this role.

EEO Statement:

Novartis is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity, veteran or marital status, disability, or any other protected status.

Accessibility and Accommodations

We are committed to providing reasonable accommodations for individuals with disabilities. If needed, contact us at [e-mail] or call [phone], including the job requisition number in your message.

Salary Range: $73,500 - $136,500

Skills Desired: Animal Models, Bioinformatics, Chemistry, Collaboration, Communication Skills, Data Analysis, Drug Discovery, Ethics, Laboratory, Lifesciences, Medical Research, Patient Care, Pharmaceutics, Physics, Problem Solving, Quality Control, Regulatory Compliance, Research, Risk Assessment, Telemetry, and others.