Documentation Specialist

Document Specialist

We are seeking a detail-oriented and organized Document Specialist to join our team. The successful candidate will assist project teams with the preparation of regulatory documents and provide project management support. As a project team member, you will support prescribed activities for client and internal projects, adhering to strict timelines and quality standards.

Key Responsibilities:

Document Management:

• Prepare and review regulatory documents, including protocols, clinical study reports, and regulatory submissions.
• Prepare content plans, organize and categorize documents, ensuring accessibility and version control.
• Incorporate draft edits with extreme attention to detail, create and finalize abbreviation tables, and manage literature references and citations.
• Support e-publishing activities (formatting, creating eCTD compliant PDFs, hyperlinking, bookmarking, etc.).

Project Coordination:

• Support project managers in coordinating activities related to regulatory submissions and project milestones.
• Coordinate with cross-functional teams to ensure completeness and accuracy of submissions.
• Track submission progress and address any queries or issues raised during the review process.
• Coordinate, organize, and participate in project team meetings, as requested.
• Conduct research for projects and archive project data in the knowledge management system at project closing.
• Prepare documents, spreadsheets, invoices, and general administrative support to senior regulatory consultants.

Quality Assurance:

• Stay up-to-date with regulatory guidelines and industry standards.
• Conduct document audits to ensure compliance with regulatory requirements, regulatory style guide, and internal standards.
• Implement corrective actions and continuous improvements to enhance document management processes.

Requirements

Who You Are:

• Experience: Proven work experience in project management
• Technology: Expert level proficiency in Windows and MS Office Suite
• Values: Embody our core values – People, Innovation, Passion and Excellence.
• Detail-Oriented: Possess a meticulous eye for accuracy and strong organizational skills.
• Team Player: Thrive in a collaborative environment and demonstrate excellent communication skills.
• Preferred, not required:
• BS/BA
• Experience within the pharmaceutical, life sciences or biotech industry
• Knowledge of Adobe Acrobat (PDF optimization, bookmarks, hyperlinks), Endnote and eCTD software

Benefits

Why VCLS:

• Make a Difference: Contribute to the development of life-saving therapies and accelerate progress in the field.
• Learn and Grow: Work alongside industry veterans and gain invaluable mentorship.
• Hybrid Flexibility: Enjoy the best of both worlds with a work-life balance that empowers you.
• Dynamic Environment: Be part of a passionate team dedicated to client success and innovation.
• Growth Potential: Build a rewarding career in a company that fosters continuous learning and development.

VCLS is committed to fostering a diverse and inclusive workplace. We are a proud equal opportunity employer and value the unique contributions of all individuals. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.