Support documentation process and records management program for the Department.
Responsible for formatting and assuring documentation meets current quality specifications.
Provide advanced word processing support for all incoming documents.
Support colleagues on use of submission templates, documents processing and fulfill any documentation needs.
Partnering with project teams and other customer groups (e.g., Managers, Cross functional teams, etc.) to ensure required contributions meet business needs and are provided in accordance with agreed time and quality standards.
Accountable for database searches and contribute to documentation workflows.
High School diploma required; Associates degree preferred
Minimum 5 years of experience
Knowledge and awareness of the functioning of the pharmaceutical industry (vaccine research and/or regulatory environment preferred)
Previous experience with documentation, documentation systems, documentum
Must have documentation management skills
Strong IT skills: advanced use of MS Word.
Previous administrative experience/skills
SOPs; process flows
Ability to understand complex issues with appropriate support; such as global and/or regional regulatory activities involved in the document filing process
Strong written and verbal communication skills.
Strong problem solving skills; organizational skills; and multiple projects flexibility.
Ability to work well with the team.
Detail oriented; precise in oral and written communication.
Must be able to present information effectively; both orally and/or in writing; in a concise; logical; and persuasive manner.
Work well under pressure and a demanding workload.