Senior Document Specialist

About the role

Appendix collection and quality checks for clinical study reports fall to this person, who keeps timelines visible across medical writers and other departments. The work follows ICH and FDA submission rules and has to land on tight deadlines.

At a glance

What you will do

• Build binders of accurate scientific documents to ICH requirements under strict timelines
• Manage appendix collection schedules and keep writers and other teams informed of milestones
• Import, export and run approval workflows inside Veeva Vault
• Quality check and approve appendix documents before they go out
• May coordinate SOP or work instruction updates and author documents within the team's scope
• Take part in training on medical writing, document types and drug development

What they look for

• Clear, concise written and spoken English
• A grasp of regulatory submission rules under FDA regulations and ICH guidelines
• Skill at juggling several projects and delivering quality work to tight, shifting deadlines
• A master's degree, or a bachelor's plus two years in the industry, or five years of relevant training and experience
• Experience managing projects, presenting and leading meetings