Manager, Clinical Documentation

Job Description

Job Description

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.

Summary:

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.

Essential Duties and Responsibilities:

SOP Management

• 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.

Document Management System Administration

• 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.

TMF (Trial Master File) Support

• 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.

Local Staff Operational Support

• 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.

Cross-Functional & Global Collaboration

• 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.

Future or Expanded Responsibilities (as organizational needs evolve)

• 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.

Supervisory Responsibility

• No direct reports; may guide junior staff or contractors.

Qualifications:

Required

• 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.

Preferred

• 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

Education:

• Bachelor’s degree in a life science, healthcare, or related field.
• 3–5+ years of relevant industry experience.

Compensation And Benefits:

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is $110,000 to $140,000 actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.

Other benefits include:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
• Career Development, Progression and Training
• Flexible Work Arrangement Programs

Applications will be accepted until June 30, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.

NS Pharma is an EEO employer.