Scientific Documentation Specialist (Fully Remote)

Alterity Therapeutics Limited; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

Alterity Therapeutics is seeking a remote US-based Document Control Specialist to support Regulatory Affairs and QA teams in clinical, nonclinical, and CMC areas. You will QC scientific documents, manage repositories, and prepare submission packages for audits and inspections.

The role requires a life sciences degree and experience with regulated documentation, along with strong attention to detail and MS Office proficiency.

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.

Responsibilities

• 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.
• 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.

Skills

Scientific document QC

Regulated documentation

Document management

Education

Bachelor's degree in life sciences or related discipline

Tools

MS Word

MS Excel

PowerPoint

Job description

• 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.
• 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.