Manager, Document Control and Training

Job not on LinkedIn

🔥 2 hours ago

🏄 California, Massachusetts, +1 more states – Remote

🏄 California – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $130k - $140k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📚 Learning and Development

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• 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.

🎯 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).