Scientific Documentation Specialist

Job not on LinkedIn

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $45 - $50 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Ignite HR Solutions

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

💼 Consulting

⚖️ Legal

🏥 Healthcare

Consulting • Legal • Healthcare

Ignite HR Solutions is an outsourced human resources consulting firm that provides comprehensive HR services to small and early-stage companies. They specialize in supporting the full employee life-cycle, from recruiting and onboarding to training, performance management, and offboarding. Ignite HR Solutions emphasizes a people-first approach, ensuring their clients receive tailored HR strategies and direct support from experienced professionals, making them a trusted partner in HR management.

📋 Description

• 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

• 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

• Medical insurance • Dental insurance • Vision insurance