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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality control review of nonclinical content, regulatory submissions, and document management, with a strong focus on Good Laboratory Practices and FDA regulations. Proficient in managing multiple projects while ensuring compliance with style guides and regulatory guidelines.
Highest-signal resume keywords
Quality Control ReviewRegulatory SubmissionsGood Laboratory PracticesVeeva SupportAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission DocumentsEditingWord FormattingPDF Submission-ReadinessDocument Lifecycle ManagementLiterature Reference ActivitiesProblem SolvingProject ManagementDrug Development ProcessElectronic Document Management
Soft Skills
Excellent Written CommunicationSound JudgmentFlexibility
Tools & Technologies
Microsoft SuiteVeevaElectronic Document Management SystemsTracking Systems
Certifications & Qualifications
Professional Certification
Industry Keywords
FDA RegulationsICH GuidelinesLife SciencesNonclinical Regulatory DocumentsCopyright Clearance
About the role
Key responsibilities & impact- Perform quality control (QC) review of nonclinical content for DMPK and Toxicology reports
- Review Module 2 and Module 4 regulatory submission documents
- Provide editing, word formatting, and PDF submission-readiness support for nonclinical regulatory submission documents
- Align documents with style guides and regulatory guidelines
- Provide Veeva support for nonclinical regulatory document lifecycle management activities
- Support literature reference-related activities, including retrieval, copyright clearance review, and upload to the electronic document management system
- Independently solve problems using sound judgment, appropriate interfacing, and flexibility in a dynamic environment
Requirements
What you’ll need- Bachelor's degree in Life Sciences
- 3 to 4+ years’ experience in relevant field
- Professional certification/credentials is a plus
- 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
- 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
Benefits
Comp & perks- 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
- Monday-Friday 8:00am-5:00pm schedule
