Document Processor, Akebia Therapeutics, Cambridge, MA
Posted April 22, 2016
Job Description
Akebia Therapeutics is seeking a Clinical and Regulatory Document Coordinator to provide operational support for all documents related to the EDMS, and establishing standard and best practices for the day-to-day operations related to the management of documents. The Document Coordinator supports the management of Trial Master Files (TMF) for clinical trials, as well as documents related to Regulatory Submissions.
Note: The job description requires at least 1 year of experience, but we would be flexible if the candidate had a Master’s degree. The job will be archival and technical, working in both an Electronic Document Management System and migrating over and archiving both paper and electronic documentation.
Additionally, the job will provide wonderful opportunities for an individual to learn all about a Trial Master File, Regulatory Submissions, and more. This is the ideal job for an entry-level candidate.
Required Skills
- Coordinates document management activities, including management of electronic trial master files (eTMF) and documents related to Regulatory Submissions. Studies may be active or closed.
- Performs QC of metadata for documents created or migrated into the system.
- Performs periodic ad hoc, interim, or end-of-study reviews/audits on paper and/or electronic files.
- Archives closed out documentation according to applicable SOPs and Record Retention. Schedule. This may include scanning and classification of documents, assisting with labeling and physically relocating study files.
- Assists with the preparation of files for Internal Audits, supports the resolution with identifying and implementing corrective actions to findings in audit reports.
- Ensures files are structured to ensure compliance with regulatory guidances and ease of rapid retrieval (inspection ready 24/7).
- Assists in writing SOPs, creating and implementing best practices, and supporting data migration.
- Coordinates EDMS change controls and updates, including addition of dictionary values.
- Creates and updates existing administrative information for company-wide viewing.
Required Experience
- Associate’s degree in a scientific or health-related field is required.
- Minimum of 1-3 years of experience in biopharmaceutical document management required.
- Minimum of 1-2 years of experience with management of clinical trials and/or regulatory submissions at a pharmaceutical/biotech company or CRO is preferred.
- Understanding of GCPs, FDA regulations and ICH guidelines is preferred.
- Familiarity with DIA TMF Reference Model is preferred.
- Experience with various documentation management systems (e.g. eTMF, Clinical Trial Management Systems [CTMS],Doc Compliance etc.) preferred.
- Must be proficient in MS Office Suite.
Job Location
Cambridge, Massachusetts, United States
Position Type
Full-Time/Regular
To apply