Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
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
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.