Preclinical Research Associate
About The Position
The Preclinical Research Associate performs quality control review of nonclinical content for DMPK and Toxicology reports and regulatory submission documents, including Module 2 and Module 4. The role also provides editing, Word formatting, and PDF submission-readiness support in alignment with style guides and regulatory guidelines; supports nonclinical regulatory document lifecycle activities in Veeva; and assists with literature references, including retrieval, copyright clearance review, and upload to an electronic document management system. The associate is expected to solve problems independently and exercise sound judgment, appropriate interfacing, and flexibility in a dynamic environment. This is a full-time position based in Boston, Massachusetts, with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m.
Requirements
- Bachelor's degree in Life Sciences.
- 3 to 4+ years of experience in a relevant field.
- In-depth knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process.
- A successful track record of managing multiple projects in a fast-paced, deadline-driven environment.
- Impeccable attention to detail and excellent written communication skills.
- Proficiency in Microsoft Suite, including Word, Excel, PowerPoint, and Visio.
Nice To Haves
- Professional certification or credentials.
- Experience with regulatory submissions.
- Experience with Veeva.
- Experience with other electronic document management or tracking systems.
Responsibilities
- Perform quality control review of nonclinical content for DMPK and Toxicology reports and regulatory submission documents, including Module 2 and Module 4.
- Edit and format documents in Word and prepare PDFs for regulatory submission in accordance with style guides and regulatory guidelines.
- Provide Veeva support for nonclinical regulatory document lifecycle management activities.
- Support literature reference activities, including retrieval, copyright clearance review, and uploading references to an electronic document management system.
- Solve problems independently, exercising sound judgment, appropriate interfacing, and flexibility in a dynamic environment.
Benefits
- Comprehensive medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- 401(k) with company match
- Paid vacation
- Paid holidays
- Yearly goal-based bonus
- Eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
