Remote Regulatory Documentation Specialist

Alterity Therapeutics Limited; United States; Remote; USD 62,000 - 69,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Job summary

Alterity Therapeutics Limited is seeking a Scientific Documentation Specialist to ensure accuracy, completeness and traceability of scientific and regulated documentation across Clinical, Nonclinical, and CMC programs. Based in Regulatory Affairs and QA, you will coordinate with investigators, clinicians and external partners to verify data against source materials and support regulatory submissions.

You will organize documents in SharePoint, Veeva Vault and other repositories, maintain filing

Qualifications

• Bachelor’s degree in life sciences, biomedical sciences, chemistry, pharmacology or related discipline.
• Experience working accurately with scientific reports, technical documents or research data.
• Ability to understand scientific terminology and compare information across multiple sources.
• Identify inconsistencies and recognize when SME review is required.
• Understanding of document control, version management, confidentiality and recordkeeping.
• Strong written communication, organization, analytical ability and attention to detail.
• Ability to manage multiple priorities and work effectively across functions.

Responsibilities

• Perform documented QC of clinical, nonclinical, CMC and regulatory documents using established procedures and checklists.
• Verify numerical values, units, tables, figures, references and statements against source records.
• Review documents for consistency of study information, terminology, data and references.
• Check formatting, numbering, terminology, cross-references and document versions.
• Record discrepancies and coordinate resolution with authors and SMEs.
• Support source verification of information in regulatory submissions and development records.
• Organize, classify and maintain documentation in SharePoint, Veeva and other repositories.
• Coordinate filing structures, metadata and workflows with QA and IT.
• Support document-management implementation activities and migration.
• Coordinate receipt and migration of records from CROs, manufacturers and consultants.
• Reconcile inventories and verify completeness, classification and transfer.
• Maintain document registers and trackers and ensure version control.

Skills

Scientific documentation QC

Source verification

Cross-functional coordination

Attention to detail

Regulatory awareness

Education

Bachelor’s degree in life sciences or related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Adobe Acrobat

SharePoint

Veeva Vault

Egnyte

Smartsheet

R

SAS

Job description

Alterity Therapeutics Limited is seeking a Scientific Documentation Specialist to ensure accuracy, completeness and traceability of scientific and regulated documentation across Clinical, Nonclinical, and CMC programs. Based in Regulatory Affairs and QA, you will coordinate with investigators, clinicians and external partners to verify data against source materials and support regulatory submissions.

You will organize documents in SharePoint, Veeva Vault and other repositories, maintain filing