Manager, Document Control and Training

Jade Biosciences•Boston, MA

1d•$130,000 - $140,000•Remote

About The Position

The Manager, Document Control and Training will support the end-to-end Document Management and Training processes. This role will support various functions within the day-to-day management and administration of the document management and training system.

Requirements

Bachelor’s degree and 5-8+ years of pharmaceutical/biotech R&D experience, including 3-5+ years of experience in Document Control
Experience administering training and documentation in Veeva Basics is a must
Strong administrative and organizational skills
Proficient in file and electronic data management systems
Excellent technical writing skills
Knowledge of records management principles and practices
Familiarity with document management software
Proficiency in using SharePoint and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Responsibilities

Support the full document lifecycle including creation, review, approval, distribution, revision, archival, and obsolescence.
Ensure controlled documentation complies with all required internal requirements including formatting of controlled documents.
Route documents for signature and ensure requirements are met.
Establish and maintain training matrices/curricula aligned to job functions.
Create and manage training and document management metrices.
Drive continuous improvement in training effectiveness (including onboarding, recurring training, and inspection preparedness) and document management processes.
Ensure accurate training records and audit-ready traceability.
Represent Document Control and Training at data reviews, including Management Review, highlighting trends, risks and improvement opportunities as requested.
Ensure that documents are properly organized, stored, and accessible to authorized personnel.
Maintain accurate logs and archives.
Oversee document version control and support report generation.
Support process and/or system related changes to the document management and training systems.
Collaborate and follow up with cross-functional teams to gather and review documentation requirements, provide system/process specific support and gather and review areas of improvement.