Document Specialist

• Format regulatory documents according to company and regulatory agency standards
• Create and maintain document templates, style guides and formatting standards
• Create and maintain submission-ready PDFs including Bookmarks, Hyperlinks, Table of Contents, page numbering, metadata etc.
• Perform quality control (QC) reviews of regulatory documents before publishing and submission.
• Ensure compliance with CTD/eCTD, NeeS, and eDok formatting requirements.
• Support preparation of dossiers for submissions to agencies such as US FDA, EMA, MHRA, Swissmedic and Health Canada
• Manage document life cycle activities, version control and archival
• Coordinate with Regulatory affairs, medical writing, CMC, Clinical and Quality teams to obtain and process submission documents
• Support Publishing teams during dossier compilation and submission activities
• Maintain submission trackers, regulatory archives and document repositories
• Monitor evolving regulatory submission standards and provide guidance to stakeholders
• Participate in the update of internal eCTD Distinct Technical Procedures (DTPs)
• Provide training and mentoring to document/eCTD Specialists (when applicable)
• Interact frequently with clients during project execution and discuss/challenge as necessary
• Proactively communicate with colleagues at all levels to ensure mutual exchange of information
• Collaborate with all regulatory teams to ensure good coordination of activities and a coherent clinical program
• Liaise with sponsor, regulatory authorities and/or service providers when appropriate
• Raise awareness of potential opportunities regarding transversal activities (eg. for other Service Units and/or Areas of Expertise and/or Geographical Areas)
• Proactively contribute to knowledge sharing within VCLS

Requirements

• Life Science Graduate + solid academic background in Life Sciences;
• Proven experience in document formatting, regulatory publishing or operations
• Experience supporting eCTD, NeeS or eDok submissions
• Knowledge of document management systems and quality-controlled environments
• Strong knowledge of Microsoft word formatting
• Experience in a consulting environment is a plus;
• Good command of MS Office (Word, Excel, PowerPoint);
• Excellent attention to detail and organizational skills
• Strong problem-solving skills, ability to work under tight deadlines and manage multiple projects
• Demonstrated ability to manage and build relationships with colleagues and regulatory authorities