Rakuten Aspyrian, Inc., is a privately funded, clinical stage Biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform. 

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses. 

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy in patients with other cancer types. 

Given the rapid progression of the clinical studies, we are quickly expanding the team to support late-stage pivotal clinical development and future commercialization of our products.

As a key member of the quality team, the Document Control System Administrator will be responsible for the execution of document QC processes, controlled document processes, and training processes. The position requires an extremely high attention to detail, hands on experience managing document control processes, and experience in QC review of documents. In addition, this individual will be responsible for configuring and maintaining the electronic document/training system, training users on its use, and expansion of its application as the company grows.  This individual will also be responsible for controlled document management, including establishing and maintaining an appropriate document hierarchy and naming structure by working cross-functionally to ensure documents, including controlled documents and development/research reports, are properly archived and retrievable.

 The Document Control System Administrator will oversee and participate in the development, implementation and validation of the Rakuten Aspyrian electronic document management system (EDMS) and electronic quality management systems (EQMS) and serve as the user based Subject Matter Expert (SME) and System Administrator (SysAdmin). This individual will establish, implement and maintain corporate and departmental procedures, protocols, reports, files, training and various other quality and corporate records within the validated EDMS. This position will be the designated System Administrator responsible for establishing/managing file hierarchy and access controls. This position will additionally administer the company electronic learning management system (LMS) and oversee a compliant training program for the company.

• May supervise other members of the Documentation Control team

• Implement, administer and maintain Rakuten Aspyrian EDMS, EQMS and LMS including execution of upgraded software validation and system integrations

• Manage systems administration for software upgrades, user functionality and support, simple system configuration, ongoing system improvement, software change management, input on system design, validation ad end user training

• Maintain the EDMS/EQMS/LMS including training users, activating/inactivating users, and system maintenance/optimization

• Serve as a liaison between the site users and the EDMS/EQMS/LMS system vendors for troubleshooting user issues

• Coordinate and troubleshoot EDMS/EQMS/LMS errors and issues between IT personnel / service reps

• Establish operational SOPs for the use, maintenance and security of the EDMS/LMS

• Perform and manage document QC activities working cross-functionally to ensure accuracy of documents/data and internal consistency, including verification of data to approved source documents, for technical reports, product labelling, and regulatory submission documents.

• Perform full editorial reviews on various regulatory document types, ensuring correct grammar, mechanics, usage, style, template adherence, etc., according to company style guide and accepted standards.

• Resolve or verify resolution of document issues with the writers/SMEs regarding QC findings, including verification that all reviewer comments have been addressed.

• Collaborate with departments (e.g., Clinical Research, Medical Writing, Regulatory Affairs) to facilitate document development, increase SOP/document quality and consistency across documents in specific programs and/or submissions.

• Coordinate the review, approval, issue and maintenance of controlled documents

• Manage QA Controlled Document change control for revisions, workflows and assignment of training tasks prior to document effectivity dating

• Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) within the quality document system to verify completeness, legibility, formatting, etc.

• Manage the periodic review of QA Controlled Documents within the EDMS and ensure compliance to SOP requirements

• Administer and maintain Rakuten Aspyrian’s training program partnering with SOP authors and hiring managers for training curriculum development, assessment documentation and training reporting

• Manage the development and delivery of training content for all departments working with Corporate Compliance including interactive software, classroom, and online

• Manage the document lifecycle management process, which includes providing guidance, formatting, content, management, archival, and retrieval of documents.

• Manage document archiving according to the retention policy.

• Manage document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications, and inspection staff).

• Other duties as assigned

• B.S. in life sciences or other relevant field

• 2 - 5 years experience performing document QC of regulatory submission documents

• 5-7 years experience administering electronic document systems

• Experience with electronic Document/Quality Management Systems required

• Expert working knowledge with WORD, Excel, Power Point, Adobe (including form building), formatting documents and e-learning content development/ authoring tools

• Excellent organizational skills and ability to meet deadlines

• Excellent oral and written communication skills. Ability to communicate across multiple levels of management and cross-functional areas

• Attention to detail and follow through

• Must be self-directed and highly motivated

• Collaborative and interpersonal skills to work in a team environment

• Ability to work with internal IT and external IT vendors to establish and maintain appropriate system configurations and validation.

• Ability to travel for purposes of training and system maintenance, as needed 

• Familiar with 21 CPR 210/211 compliance, Systems Development Lifecycle (SDLC), and Information Security requirements

• Experience in implementing, validating, and maintaining GxP document management, integrated 3rd party, and training systems

• Experience managing quality-controlled documents, revision workflows and document change control processes

• Experience in the management and administration of a GXP/compliance training program

• Experience in implementing and maintaining validated computer systems

• Experience managing quality-controlled documents, revision workflows and document change control processes

• Experience in troubleshooting user system problems and solution testing and documentation per IT and QA Change Control requirements

• Management and administration of a GXP compliance training program