Scientific 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

The Scientific Documentation Specialist provides cross-functional scientific documentation support to help ensure the accuracy, completeness, consistency, traceability, and accessibility of Alterity’s scientific and regulated documentation.

The role combines scientific document quality control and source verification with document and information management activities. Based within Regulatory Affairs and Quality Assurance, the role works across Clinical, Nonclinical and Chemistry, Manufacturing and Controls (CMC) to organize and maintain documentation, verify information against designated source materials, and support regulatory submissions, audits, inspections and due diligence.

Priorities will be agreed with the line manager in consultation with functional leads. The breadth and focus of responsibilities will evolve based on program priorities, organizational needs, and demonstrated capabilities. The position reports to the VP, Regulatory Affairs and Quality Assurance.

Key Responsibilities

Scientific Documentation and Quality Control

• Perform documented QC of clinical, nonclinical, CMC and regulatory documents using established procedures and checklists.
• Verify numerical values, units, tables, figures, references and factual statements against designated source reports, datasets, approved outputs or supporting records.
• Review related documents for consistency of study information, terminology, data, document identifiers and scientific content.
• Check formatting, numbering, terminology, cross-references, references and document versions.
• Record discrepancies and queries, coordinate resolution with authors and subject‑matter experts, and track corrections to closure.
• Support source verification of information incorporated into regulatory submission documents and other key development records.

Document Management and Systems

• Organize, classify and maintain scientific, regulatory and quality documentation in SharePoint, Veeva and other designated document repositories.
• Coordinate implementation and improvement of document filing structures, naming conventions, metadata and workflows with Regulatory/QA, functional leads, IT and system providers.
• Support document‑management and filing‑system implementation activities, including requirements gathering, document organization, migration, reconciliation and user guidance.
• Coordinate receipt and migration of records from CROs, manufacturers, consultants and legacy repositories.
• Reconcile document inventories and verify completeness, appropriate classification and successful transfer.
• Maintain document registers and trackers and identify missing, duplicate, superseded or incorrectly filed records for resolution with document owners.
• Support appropriate version control, review, approval, retrieval and archiving practices.

Cross‑Functional Coordination and Readiness

• Work with Regulatory Affairs, Quality Assurance, Clinical, Nonclinical and CMC teams to support documentation needs and agreed program priorities.
• Coordinate document review and approval cycles and follow up on outstanding inputs and deliverables.
• Prepare and retrieve document packages for regulatory submissions, audits, inspections and due diligence, maintaining traceability to approved source records.
• Maintain practical QC checklists, filing guides, templates and work instructions.
• Support user onboarding and consistent document‑management practices.
• Identify opportunities to improve document quality, traceability, accessibility and efficiency.

Education and Qualifications

Required

• Bachelor’s degree in life sciences, biomedical sciences, chemistry, pharmacology or a related scientific discipline.
• Demonstrated experience working accurately with scientific reports, technical documents or research data through industry, research, internships or substantial academic work.
• Ability to understand scientific terminology and concepts and to compare information across multiple sources.
• Ability to identify inconsistencies, discrepancies and potential errors and recognize when review by a functional subject‑matter expert is required.
• Understanding of document control, version management, confidentiality and accurate recordkeeping.
• Strong written communication, organization, analytical ability and attention to detail.
• Ability to manage multiple priorities and work effectively across functions.

Preferred

• One to three years of relevant experience in biotechnology, pharmaceuticals, a CRO or another regulated scientific environment.
• Experience with scientific document QC, regulatory documentation, controlled records, document management or document migration.
• Familiarity with clinical, nonclinical, CMC or regulatory submissions.
• Working knowledge of GCP, GLP and/or GMP and associated documentation and data‑integrity principles.

Technical / Software Knowledge

• Microsoft Word, Excel, PowerPoint
• Adobe Acrobat
• SharePoint
• Veeva Vault or equivalent electronic document management systems
• Egnyte
• Smartsheet
• R - asset
• SAS - asset

Working Relationships and Accountability

• The Scientific Documentation Specialist works closely with Regulatory Affairs, Quality Assurance, Clinical, Nonclinical, CMC, medical writers and external service providers.
• The role performs scientific document QC, source verification and document‑management activities within an agreed scope and with appropriate training and subject‑matter support.
• Scientific interpretation, technical decisions and final content approval remain the responsibility of the appropriate functional experts.
• System ownership, access administration, configuration and validation remain with designated system owners; the Scientific Documentation Specialist supports and coordinates document organization, implementation and operational activities.

Expected Outcomes

• Scientific and regulated documents are consistently organized, readily retrievable and identifiable by current status and version.
• Data, references and factual information are appropriately verified against designated source materials.
• QC findings and source discrepancies are documented, traceable and resolved before document finalization.
• Cross‑functional teams receive reliable scientific documentation support within agreed timelines.
• Document repositories and filing practices support regulatory, quality, development and business‑readiness needs.

Location: Remote- US‑based candidates

Pay Range (based on National Average): $45.00-50.00 per hour.

Benefits include: Medical, dental, and vision insurance