Bachelor's degree in Life Sciences with 3-4+ years of relevant experience.
In-depth knowledge of Good Laboratory Practices, FDA regulations, and ICH guidelines.
Proven ability to manage multiple projects in a fast-paced environment.
Impeccable attention to detail and strong written communication skills.
Proficient in Microsoft® Suite; experience with Veeva preferred.
Responsibilities
Perform quality control review of nonclinical content for DMPK and Toxicology reports.
Edit and format nonclinical regulatory submission documents according to style guides.
Ensure PDF submission readiness for regulatory documents.
Provide Veeva support for nonclinical regulatory document management.
Assist with literature reference activities, including retrieval and copyright clearance.
Independently solve problems and exercise sound judgment in a dynamic environment.
Benefits
Comprehensive medical coverage, dental, and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Yearly goal-based bonus and eligibility for merit-based increases.
Full Job Description
Job Description
Performs quality control (QC) review of nonclinical content for various DMPK and Toxicology reports as well as Module 2, Module 4 of regulatory submission documents.
Provides editing, word formatting, and PDF submission-readiness support for nonclinical regulatory submission documents in alignment with style guides and regulatory guidelines.
Provides Veeva support for various nonclinical regulatory document lifecycle management activities.
Supports literature reference-related activities, including (but not limited to), retrieval, copyright clearance review, upload to electronic document management system, etc.
Independently solve problems, exercising sound judgment, appropriate interfacing, and flexibility within a dynamic environment.
Qualifications
Bachelor's degree in Life Sciences with 3 to 4+ years' experience in relevant field. Professional certification/credentials, experience with regulatory submissions is a plus.
In-depth knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process.
Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
Impeccable attention to detail and excellent written communication skills.
Must be proficient in Microsoft® Suite (Word, Excel, PowerPoint, Visio). Experience with Veeva is preferred. Experience with other electronic document management and/or tracking systems is a plus.
Additional Information
This is a full-time position, Monday-Friday 8:00am-5:00pm, based in Boston, MA.
What we offer:
Comp: $90-100k
Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Yearly goal-based bonus & eligibility for merit-based increases
About Eurofins Lancaster Laboratories
Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
