VCLS
WebsiteDocument Specialist
Job description
- 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
- 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
