Description
An opportunity has arisen for an experienced regulatory publisher to join a global publishing team. You will have extensive publishing experience within the pharmaceutical industry and have excellent IT and communications skills.
Description:
The Publishing Specialist works with a team of Regulatory Affairs (RA) experts to plan, assemble and publish regulatory submissions for despatch to regional health authorities or to local affiliates. The primary focus is on regulatory submissions of moderate complexity in eCTD, NeeS and paper formats. The broad range of submission types include development submissions (Briefing Books, CTAs, INDs, MAAs, NDAs), maintenance submissions (Variations, Amendments, Supplements) and mandatory submissions (Annual Reports, Safety Reports, Renewals, Responses).
Key responsibilities include (but are not limited to):
- Interact with all publishing contributors and responsible RA professionals, to ensure the timely delivery of dossier components.
- Use electronic document management and publishing tools to plan, assemble and publish dossiers according to regulatory requirements for paper and electronic submissions, with limited supervision.
- QC electronic and paper submissions to ensure compliance with company and agency requirements, before despatch.
- Escalate issues that affect submission timing, cost or quality, to the Regulatory Operations Manager.
- Perform post-submission archiving and submission tracking activities.
- Ensure document templates are used and submission document formatting standards are followed, or reformat documents as appropriate.
The successful candidate will preferably have:
- Four years of experience in a comparable role in the pharmaceutical industry.
- Excellent coordination and organisational skills and thrive on multi-tasking with regular or daily deadlines.
- Ability to plan and prioritise.
- High attention to detail and accuracy.
- Significant experience using electronic document management systems (Documentum based), document control standards and filing/archiving responsibilities.
- Expertise in submission publishing tools (eCTD Xpress and ISI Publisher), Adobe plug-ins (ISI Toolbox).
- An advanced knowledge of Microsoft Office.
- Knowledge of the drug development process and of the regulatory submission/Health Authority requirements for submission formats (eCTD, NeeS, Paper)
- Strong verbal and written communication skills.
- Strong analytical and problem solving skills.
- Ability to work independently or as part of a team.