Scientific Documentation Specialist

Ignite HR Solutions

. Perform documented QC of clinical, nonclinical, CMC and regulatory documents using established procedures and checklists .

Posted 10/23/2026full-timeRemote • United StatesMid-LevelSenior💰 $45 - $50 per hourWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

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
Organize, classify and maintain scientific, regulatory and quality documentation in SharePoint, Veeva and other designated repositories
Coordinate implementation and improvement of document filing structures, naming conventions, metadata and workflows
Support document-management and filing-system implementation, 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Maintain document registers and trackers and identify missing, duplicate, superseded or incorrectly filed records
Support version control, review, approval, retrieval and archiving practices
Work with Regulatory Affairs, Quality Assurance, Clinical, Nonclinical and CMC teams on documentation needs and 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 while maintaining source traceability
Maintain 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

Requirements

What you’ll need

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 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
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
Microsoft Word, Excel and PowerPoint
Adobe Acrobat
SharePoint
Veeva Vault or equivalent electronic document management systems
Egnyte
Smartsheet
R and SAS are assets

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance