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 for ASP-1929 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 of ASP-1929 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 Senior Document QC and Systems 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 regulatory submission documents. In addition, this individual will be responsible for 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. This position reports to a Document Manager and will be responsible for establishing, arranging and maintaining all controlled documents, procedures, reports, files, training records and scanned files. This position will be the designated System Administrator responsible for establishing/managing file hierarchy and access controls.
Key Duties and Responsibilities
Essential job functions include:
- 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.
- Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) within the quality document system to verify completeness, legibility, formatting, etc.
- Maintain the document management system, including training users, activating/inactivating users, and system maintenance/optimization.
- 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
Desired Education, Skills and Experience
- B.S. in life sciences or other relevant field
- 2 - 5 years experience performing document QC of regulatory submission documents
- 2-5 years experience administering electronic document systems
- Experience with electronic Document/Quality Management Systems a must
- Expert working knowledge with WORD, Excel, Adobe (including form building) and formatting documents
- Excellent organizational skills and ability to meet deadlines
- 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
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.
Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebratediversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.