Document Specialist Consultant

Position: Document Specialist Consultant

Work Arrangement: South Africa--Remote (aligned with US time zones)

Engagement Type: Consultant

Estimated Commitment: Approximately 40 hours per month

Initial Duration: 6–12 months, with potential for extension

Position Overview

Peritia is supporting a midsize, global biopharmaceutical company with late-stage clinical development programs and global regulatory submissions. The organization is seeking a detail-oriented Document Specialist Consultant to support its Medical Writing department in ensuring the quality, consistency, compliance, and lifecycle management of clinical and regulatory documents.

The ideal candidate will have strong technical document management and quality control experience within the pharmaceutical or biotechnology industry, along with hands‑on experience using electronic document management systems (eDMS), particularly Veeva Vault.

Key Responsibilities

Document Management and Lifecycle Control

• Manage the creation, routing, review, approval, version control, and archiving of clinical and regulatory documents.
• Ensure documents follow established templates, formatting standards, naming conventions, metadata requirements, and folder structures.
• Maintain accurate document records and support document traceability throughout the lifecycle.

Document Quality Control

• Perform electronic quality control (eQC) reviews of clinical and regulatory documents, including:
• Clinical study protocols
• Clinical Study Reports (CSRs)
• Integrated summaries
• Health Authority (HA) responses
• Verify document formatting, consistency, completeness, references, hyperlinks, and adherence to applicable templates and style guidelines.
• Identify discrepancies, resolve formatting issues, and escalate significant quality concerns.

Electronic Document Management Systems

• Use Veeva Vault and/or other electronic document management systems to manage document workflows and maintain accurate records.
• Support document metadata management, version tracking, archival activities, and inspection readiness.
• Assist with copyright clearances and related document compliance requirements.

Cross-Functional Collaboration

• Partner with Medical Writing, Regulatory Affairs, Clinical Operations, and other stakeholders to coordinate document reviews and approvals.
• Communicate document status, timelines, and outstanding actions to relevant stakeholders.
• Escalate potential delays, process issues, and quality risks promptly.

Compliance and Process Improvement

• Support compliance with applicable ICH guidelines, regulatory requirements, and internal document management procedures.
• Maintain organized, inspection-ready documentation and support audit or inspection activities.
• Identify opportunities to improve document quality, consistency, and workflow efficiency.

Required Qualifications:

• Bachelor’s degree required; an advanced degree is preferred.
• At least 3 years of technical documentation experience in the pharmaceutical or biotechnology industry, or an advanced degree combined with at least 1.5 years of medical writing or document quality control experience.
• Strong understanding of clinical development and regulatory documentation.
• Hands‑on experience with Veeva Vault or another electronic document management system.
• Advanced proficiency in Microsoft Word, including complex formatting, styles, templates, and document layout.
• Working knowledge of Microsoft Excel and Adobe Acrobat.
• Familiarity with document naming conventions, folder structures, metadata management, and version control.
• Experience conducting document quality checks and supporting audit or inspection readiness.

Preferred Skills and Competencies

• Six or more years of medical writing, technical documentation, or document quality control experience.
• Strong attention to detail and a commitment to document accuracy and consistency.
• Excellent organizational and time-management skills.
• Clear written and verbal communication skills.
• Ability to work independently, exercise sound judgment, and elevate issues appropriately.
• Service-oriented, adaptable, and comfortable working in a cross‑functional, matrixed environment.
• Ability to manage confidential information and take accountability for assigned deliverables.
• A proactive mindset focused on continuous learning and process improvement.
• Workload: Approximately 40 hours per month, with periodic increases around major regulatory submission