- Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier is prepared ready to submit to the FDA and other agencies. This includes,
- Publishing(Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, CRFs and eCRF Pre-Meeting packages, Labeling)
- Knowledge in building different types of submission.
- Peer Reviewing of other group members’ documents.
- Experience in publishing the documents globally(MAA submission & Health Canada).
- Experience in Processing SAE’s and OPDP submission
- Knowledge in preparing Paper submission, scanning documents and Printing Desk copies (Internal or Health Authority).
- Minimum of 3 – 4 years experience in Regulatory Affairs publishing and reviewing the documents in a pharmaceutical environment, with strong familiarity with regulatory eCTD submission process.
- Must be highly proficient in Microsoft office, Adobe Acrobat, ISI writer and ISI Toolbox (with proven background in bookmarking and Hyperlink, page stamp, masking and watermarks etc,).
- Knowledge of eCTD submission eCTD Validator(Lorenz and Global Submit), eCTD Viewer and Life Cycle Management Experience in using different application like viewpoint, Coredossier or eCTDExpress etc (TRS Publisher, TRS TRACKER and Document management systems like First Doc)
- Knowledge in scanning document.
- Knowledge in FDA & ICH Guidance’s
- Must be able to do multi-task and work well under tight timeliness.
- MUST HAVES: eCTD XPress, TRS publisher and knowledge in MAA and Health Canada submissions
Company offers very competitive hourly rate for contract role and great working environment.