REGULATORY AFFAIRS OPERATIONS & PUBLISHING - CAMBRIDGE

REGULATORY OPERATIONS AND PUBLISHING OFFICER 20 000 - 28 000. ectd, adobe acrobat, dossier.

Our client is the top performing biopharmaceutical company looking for a Operations and Publishing Specialist. You will be involved in:

Prepare a variety of routine and non-routine submissions including utilization of publishing tools for electronic and paper submission generation, scanning, QC, and electronic and paper archival in partnership with Central Records.

May participate in supporting and promoting electronic initiatives in moving the company forward with electronic submissions and electronic archives.

May participate in submission planning meetings to become familiar with the submission priorities.

May interface with project managers, regulatory product managers, and or content authors to discuss routine and non-routine submission preparation and content.

Processing activities associated with the preparation of submission-standard regulatory documents for both hard copy and electronic submissions.

Assists with the compilation of routine documents such as clinical study reports and application dossiers. Ensures final document components are electronically archived according to the departmental practices. Participates in the development or upgrading of templates as well as guidance documents and SOPs that relate to document standards, content and processes.

Experience

The position requires a good understanding of MS Word, Word templates, Adobe Acrobat and standard Office tools.
Must be able to master new technical skills and apply them to projects as the industry, and the company, evolves.
Experience in document management and Regulatory publishing is required. Some experience in working with electronic document management systems is required.
Some familiarity with pharmaceutical development and Regulatory global submissions is required.
Experience in document management and Regulatory publishing.
Experience in working with electronic document management systems.
Excellent knowledge of MS Word, Word templates, Adobe Acrobat Experience of working with an eCTD tool.

For more information regarding this vacancy please contact Abid Kanji on 0207 940 2108 or email him at [Email hidden]