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Role Overview:
- Provide cross-functional scientific documentation support to ensure accuracy, completeness, and traceability.
- Work within Regulatory Affairs and Quality Assurance to support clinical, nonclinical, and CMC teams.
Key Responsibilities:
- Perform QC checks on scientific and regulated documents using established procedures and checklists.
- Manage document repositories, filing structures, metadata, and workflows in systems like SharePoint and Veeva.
- Prepare and retrieve document packages for regulatory submissions, audits, inspections, and due diligence.
Qualifications:
- Bachelor's degree in life sciences, biomedical sciences, chemistry, pharmacology, or related discipline.
- Experience with scientific document QC, regulated documentation, or document management is preferred.
- Strong attention to detail, analytical ability, and proficiency with Microsoft Word, Excel, and PowerPoint.
Work Environment:
- Fully remote position for US-based candidates.
- Reports to VP, Regulatory Affairs and Quality Assurance and collaborates with Regulatory, QA, Clinical, Nonclinical, and CMC teams.
Alterity Therapeutics
Alterity Therapeutics is a late-stage clinical biotechnology company focused on developing disease-modifying treatments for rare and debilitating neurodegenerative disorders. They operate with a cross-functional team that prioritizes regulatory and quality excellence to support clinical development.