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About the Role

The Manager, Document Control and Training will support the end-to-end Document Management and Training processes, assisting with the day-to-day management and administration of the document management and training system.

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 and document management processes.
• Ensure accurate training records and audit-ready traceability.
• Represent Document Control and Training at data reviews, highlighting trends, risks and improvement opportunities.
• 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.

Requirements

• Bachelor’s degree and 5-8+ years of pharmaceutical/biotech R&D experience.
• 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).

Skills

• Veeva Basics
• File and electronic data management systems
• Technical writing
• Records management
• Document management software
• SharePoint
• Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)

Location

• Remote

Work Type

• Remote
• Full-time

Experience Level

• 5-8+ years of pharmaceutical/biotech R&D experience
• 3-5+ years of experience in Document Control

Education Level

• Bachelor’s degree

Salary/Compensations

• $130,000 - $140,000

About the Company

• Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases.
• Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy.
• Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development.
• Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount.

Equal Opportunity

• Jade Bioscience participates in E-Verify.
• Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.