After minimum 12 months – depending on the speed of the development – after manager approval, Junior Publishing Specialist is promoted to Publishing Specialist, until that time Junior Publishing Specialist can only work under supervision by Publishing Specialist or Senior Publishing Specialist.
1. Primary Responsibilities
· Compilation and publishing expertise in the preparation of new and existing regulatory applications including initial applications (CTAs, INDs, MAAs, NDAs etc.), amendments, supplements, variations and other submissions in compliance with health authority regulations
· Primary focus is on regulatory submissions of moderate to high complexity both eCTD and non-eCTD format, including all Modules accountability for large submissions under supervision
2. Submission coordination and publishing tasks
· Compilation of paper submissions and assembly of electronic submissions in eCTD including tracking progress of document delivery, gathering metrics for submission processing, quality assurance, releasing and archiving in accordance with SOPs and guidance documents under supervision.
· Perform publishing activities using various electronic technologies including electronic publishing (e.g. gCTD, InSight Publisher) and electronic Document Management (IDM)
· Ensure documents are compliant with Client standards and ICH guidelines. Bookmark and hyperlink PDF documents to ensure adherence to ICH guidelines for incorporation into eCTD submissions using PDF editing tools including Adobe Acrobat and ISI Toolbox
· Publishing and submission activities for TRICs submissions (Technical Regulatory information change)
· Ensure overall submission quality
3. Coordination of EU Product Information Annexes (EU Specific)
· Provide support in the preparation of the English Annexes, initiate & coordinate translation activities.
· Liaise between the Product management teams and the worldwide pharmaceutical Affiliates to get relevant questionnaires completed
4. PDR Support
· Communicate and advise product teams / individuals on RSG publishing requirements
5. Training and process support
· Assist in assuring adherence to current publishing processes and standards and support development of new publishing standards and processes
· Contribute to the improvement of submission processes and working practices through working groups, submission debrief meetings.
· Degrees: Bachelor’s Degree in Life Sciences
Skills & Qualifications
· Excellent oral and written communication skills in English
· Excellent attention to details
· IT skills – Very good command of Microsoft Office and Adobe Acrobat
· Regulatory publishing experience
· Working knowledge of document management and publishing software and supporting tools
· Regulatory Knowledge – working knowledge of ICH, FDA, EU dossier structural requirements