Manager, Document Control and Training

Manager, Document Control and Training

Boston; Remote; San Francisco; Seattle

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.

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.

Key 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 metrics.
• 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.

Qualifications

• 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).

Position Location

This is a remote role; periodic travel to team and company events is required.

The anticipated salary range for candidates for this role is $130,000 - $140,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

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.