This internship will be under the supervision of a Clinical Publishing Manager responsible for clinical trials documents in the Oncology, Endocrinology or Neurology Therapeutic Areas.
The placement will offer a broad insight into the workings of our busy Medical Writing and Clinical Publishing Department whose job it is to write and publish the results of clinical trials for submission to regulatory authorities. This position will also offer the opportunity to build interactions with other key functions involved in pharmaceutical Research and Development (R&D) including Dossier Management, Regulatory Affairs, Non-Clinical Pharmacology, Data Management, Clinical Operations and Pharmacovigilance. The placement will involve regular shadowing of and mentoring by a Clinical Publisher and the support of a departmental "buddy".
KEY ACCOUNTABILITIES & ACTIVITIES
Examples of activities that the intern may be involved in include:
Retrieval of documents from internal archive, scanning and conversion to Adobe Acrobat pdf format
Manipulation of pdf documents to the desired page format, adding appropriate electronic navigation including bookmarks and hyperlinks
Assessment of documents for completeness and quality and completion of Medical Writing Quality Verification (MWQV) processes
Completion of activities within the framework and in compliance with the International Conference on Harmonisation (ICH) Guidelines and Ipsen SOPs
Work to ensure high quality, timely and accurate completion of Clinical Publishing tasks
Provision of regular updates to the Clinical Publishing Manager
Assistance with the planning and tracking of components of pharmaceutical dossiers in collaboration with the Clinical Publishing Manager and the project team
Manipulation of electronic documents to ensure that the format and quality of presentation are compliant with the technical requirements of regulatory authorities
Performance of document remediation using specialist software tools to create the appropriate electronic navigation such as bookmarks and hyperlinks
Import of documents into our commercial Electronic Document Management System (EDMS) and management of workflows under supervision of the Clinical Publisher
Performance of report level publishing using specialist software tools and production of professionally published reports under supervision of the Clinical Publisher.