Manager, Clinical Documentation

NS Pharma Inc•Paramus, NJ

just now

About The Position

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. This position is responsible for supporting and maintaining the Quality Management System (QMS) for clinical research activities conducted in the U.S., including SOP lifecycle management, document management system administration, user access control, TMF support, and operational assistance for local staff. The role works closely with the Associate Director and collaborates with cross-functional teams in the U.S. and Japan Headquarters to ensure compliance with applicable regulations (FDA, ICH-GCP) and internal standards.

Requirements

Experience in clinical research, clinical operations, quality, or document management within the pharmaceutical/biotech/CRO industry.
Strong understanding of FDA regulations and ICH-GCP guidelines.
Hands-on experience with document management systems (eTMF, CTMS, DMS, or similar).
Excellent communication skills and ability to work in a multicultural, global environment.
Strong organizational skills and ability to manage multiple priorities simultaneously.
Ability to proactively identify issues, propose solutions, and support continuous improvement.
Bachelor’s degree in a life science, healthcare, or related field.
3–5+ years of relevant industry experience.

Nice To Haves

Experience managing SOP lifecycle processes or QMS operations.
Knowledge of TMF structure, filing expectations, and inspection readiness.
Experience supporting audits/inspections.
Japanese language skills a plus (not required).
Experience with Veeva Vault (eTMF, QualityDocs, or CTMS)
Experience supporting vendor management, Issue/Risk Management

Responsibilities

Maintain and update SOPs and controlled documents in accordance with internal procedures and regulatory requirements.
Coordinate SOP revisions, reviews, approval workflows, and periodic updates.
Track and manage SOP training compliance for local staff/Expats.
Serve as system administrator for the Document Management System (e.g., user provisioning, access rights, permission changes, issue troubleshooting).
Provide onboarding and ongoing training to users on document management processes and system usage.
Ensure compliance with established document governance standards.
Provide operational support for TMF processes, including quality checks, filing accuracy, and document completeness.
Coordinate with CROs and internal teams to ensure TMF inspection readiness.
Assist in implementing TMF standards, filing plans, and quality review processes.
Act as a primary point of contact for U.S.-based team members for QMS- and documentation-related matters.
Provide guidance and troubleshooting on SOP interpretation, documentation workflows, and compliance expectations.
Support audits and inspections by preparing relevant documentation and coordinating responses.
Collaborate with Japan Headquarters teams to ensure alignment of quality and documentation standards.
Participate in global or regional meetings related to QMS, SOPs, and document management.
Contribute to harmonization projects for global SOPs, templates, and processes.
Support clinical team regarding vendor oversight processes, including documentation tracking and compliance checks.
Provide operational support to study teams using Veeva applications (e.g., Vault, eTMF, Quality Docs).
Participate in broader Quality Management System initiatives as needed.