The Documentation Specialist will develop, process, and maintain the Quality Systems Documentation System to comply with GXPs. This includes the systems to support regulatory submissions, clinical documentation, and manufacturing documentation. Must be able to handle multiple responsibilities and have the ability to interact effectively with other departments and functional groups at various management levels. Must have an understanding and work knowledge of GLPs, GCPs, and GMPs.
- Develop and manage clinical documentation and database
- Develop systems and procedures for archiving and maintaining regulatory records, submissions, and cGMP documents.
- Creation and implementation of the master template, content templates, styles and formatting of documents. Train authors as necessary.
- Create and maintain electronic copies of Document Control, Clinical Key Documents and other technical documents.
- Process documents and coordinate publishing activities for cGMP documents. Edit, format, produce, distribute, and track cGMP and regulatory documents and records in paper and electronic format.
- Coordinate with product teams/document authors to obtain all appropriate documents in a timely manner.
- Scan, hyperlink and bookmark approved documents as necessary.
- Other duties as assigned in support of Clinical, CMC, Non-Clinical, and Regulatory teams
- Requires bachelors degree in life science or related scientific discipline.
- Proficiency using Microsoft Office suite of applications (Word, Excel, PowerPoint, Visio, Project) for the PC, knowledge of publishing applications, desktop systems with an ability to learn new applications or procedures with minimal guidance.
- 3+ years in a publishing role
- Ability to work under pressure and with minimal direction to meet tight timelines
- Excellent written communication skills.
- Excellent planning and organizational skills
- Experience in biotech or pharmaceutical industry. Familiarity with regulatory submissions and regulatory documentation systems.
To apply, submit a resume and cover letter with salary expectations via email to firstname.lastname@example.org
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