Documentation Manager

Title : Research Quality Operations Document Manager

Work Location : New Haven, CT 06510

Pay Rate : $42.00 / hr

Duration : 6 Months contract

Reports To : Associate Director, Research

Department : Quality Operations

MUST HAVE SKILLS : Veeva Vault, EDMS, Technical Writing / Editing, Regulatory Requirements.

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

Qualifications

Education

Salary : $42