Position Summary
The Research Quality Operations Document Manager oversees the maintenance of a
controlled documentation system to ensure compliance with regulatory standards and
corporate policies. This role involves technical writing and editing for various
documents within a modern software development environment. Responsibilities
include tracking and reviewing change control documentation, as well as assisting in
the editing of quality documents such as Standard Operating Procedures (SOPs),
guidelines, policies, and work instructions. The ability to work swiftly while upholding
high accuracy is essential.
The ideal candidate should possess strong interpersonal and information-gathering
skills, enabling effective communication with individuals at all levels within the
organization. The candidate should be adept at working both independently and within
a team, demonstrating the ability to interact effectively with others. Additionally,
responsibilities include reviewing current documents, incorporating feedback from
project leaders and subject matter experts (SMEs), navigating the Veeva Document
Management System (Veeva) using existing templates, and communicating workflow
status and issues to project leaders or SMEs.
Principal Responsibilities
* You will be responsible for designing, developing, and updating change
control documentation.
* Performing technical writing and editing for all types of documentation in
the Veeva Document Management System.
* Tracking and reviewing change control documentation and assisting with
the editing of quality documents such as SOPs, guidelines, instructions,
etc., to ensure compliance with regulatory requirements.
* Reviewing current documents and incorporating comments from project
leaders and other SMEs
* Navigating through the Veeva Document Management System and using
current templates.
* Notifying document authors and business owners about the workflow
status and issues.
Qualifications
* Must possess sound interpersonal and information-gathering skills,
enabling you to relate well to others at all levels throughout the
organization
* Proficient in technical writing abilities and strong time management
* Strong root cause analysis skills with experience in quality standards
* Ability to establish working relationships with support areas to gather
necessary information
* Proficient in Veeva Document Management System with proven
experience in using templates, as well as knowledge of Veeva workflows,
and approval processes.
* Proficient in MS Word, Excel, PowerPoint, and Outlook
* Self-motivated with a proactive approach to resolving issues
* Excellent verbal and written communication skills
* Ability to work effectively in a team environment and independently
Education
* College or university graduate preferred.
* Secondary Education diploma is a requirement.
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