Sr. SOP Specialist is responsible for lifecycle management of local procedure documents and training planning.
This job holder also facilitates evaluation of global process with internal and external stakeholder functions for implementation in Janssen Japan R&D
・ Perform Assessment of global level procedural documents for implementation in Janssen Japan R&D.
・ Ensure local exceptions to global procedural documents are appropriately developed and maintained, if applicable.
・ Facilitate implementation of global and local procedural documents.
・ Manage life cycle of local procedure documents such as creation, revision, archival and obsolescence in the EDMS
・ Ensure local procedural documents comply with company and GxP requirements.
・ Conduct quality review during procedure document management and collaborates with key stakeholders to resolve the review result.
・ Lead change control of local process and implementation of global process.
・ Manage to identify and maintain document property data in the EDMS to allow for accurate categorization, retrieval and reporting of procedural documents.
・ Retrieve procedural documents from the EDMS upon request in support of inspections by health authorities and internal audits across documents.
・ Perform other duties as assigned by department leadership.
・ Manage training assignments of procedural document in collaboration with business process owners and Training
・ Support business process owner to identify training types, targeted audiences and appropriate training materials.
・ Leads or supports projects, meetings, etc. as directed by Group Manager/Director, Quality and Compliance Management including but not limited to process improvement, inspection readiness, and remediation.
・ Perform TruVault Administrative activities.
・ Collaborate with local and central business partners to facilitate HA inspections and office audits as needed (e.g., preparation of pre-requirement documents, direct support during inspections/audits).
・ Facilitating the document review process.
・ Communicating the issuance of new/revised procedural documents, notification of obsoleted documents and cascading the notification to respective organizations.
・ Participate in cross-pharma and Pharm sector procedural document management activities, as needed.
・ Perform draft review for new/revised procedure documents and coordinate local review if requested.
・ Support central functions in ensuring local intelligence is up to date (e.g., T-Race, IRON).
・ Serve as local helpdesk for GCP and local regulation issues and questions.
・ Maintain and update the internal database of procedure documents for GCP inspection by Japanese Health Authority.
・ Ensure the creation of ToC of procedure documents in collaboration with related department for GCP inspection by Japanese Health Authority.
・ Report to Drug Safety Control Manager monthly update status of local procedural documents related to GVP.
・ Minimum of 5 years of previous Pharmaceutical Industry experience, preferably in R&D
・ Sound knowledge of the drug development process related local regulations and requirements, such as GCP/GPSP/GVP/GLP/GMP/GDP (scope is only clinical part for GMP and GDP). compliance regulations, research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques
・ Ability to plan, organize, coordinate, manage, and execute assigned tasks independently
・ Ability to apply knowledge of the ICH Guidelines; must be familiar with Japanese regulations, FDA regulations and the EU Clinical Trial Directive and regulations, as applicable
・ Ability to apply advanced knowledge of Microsoft Office (Word, PowerPoint, Excel) and an Audio Response System.
Janssen Pharmaceutical K.K. (7195)
Clinical Research non-MD