Senior Associate - Regulatory Publishing
Senior Associate position in Regulatory Publishing at large biopharmaceutical company for 12 month contract
Summary about this job
Pharmaceuticals & Medical Devices
Company: Pharmaceutical & Medical Professionals, an HPG Business
Location: Sydney
Work type: Contract/Temp
Salary: n\a
Phone: +61-8-9836-6345
Fax: +61-7-3299-9216
E-mail: n\a
Site: n\a
Detail information about job Senior Associate - Regulatory Publishing. Terms and conditions vacancy
About the company
With a very attractive, growing pipeline across a range of highly specialised therapeutic areas, this organisation is recognised for its great working culture, supportive team environment and the opportunity of working with some of the highest calibre regulatory staff in Sydney.
About the opportunity
Your core focus will be to facilitate product development and global registration through the efficient preparation, management and tracking of regulatory documentation and systems. This is a key international role with both local and international exposure to Asian, Australian & New Zealand regulatory dossiers.
Duties
- Work as part of a global Regulatory Operations team
- Lead key submissions for Australia and New Zealand, and contribute to Established and Emerging Markets
- Compilation and publishing of submission dossiers for established and the emerging markets for clinical trials, paediatrics and marketing applications
- Work closely with submission content providers to advise on submission content, structure, planning and strategy
- Work with publishing vendors
- Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations
- Preparation of submission ready components from source documents according to regional regulatory agency guidance
- Document management of ongoing submissions
- Quality control of submission ready components and submission dossiers
- Preparation, dispatch and tracking of electronic and paper media
- Maintenance of submission information in Regulatory Registration Tracking system and regional/global metrics
- Contribute to regional/global technical manuals and training documentation
Skills and Experience
- Degree or equivalent combination of experience and knowledge
- Knowledge of eCTD
- Minimum of 2 years of established regulatory publishing experience within the pharmaceutical industry or significant transferable knowledge of pharmaceutical/biotech industry
- Advanced knowledge of MS word and Adobe Acrobat
- Use of specialist publishing software to prepare submissions - Insight Publisher preferred
- Use of electronic document management systems
Benefits
- Opportunity to grow your in-market experience to also include regional and global experience
- Work closely with global regulatory publishing teams to hone your publishing skills to global best-practice
- Work with an organisation frequently awarded for its employee engagement
How to Apply
Click apply or contact Angela Barclay, Divisional Manager on 02 8877 8743 for a confidential discussion.
About us
Pharmaceutical & Medical Professionals, a Healthcare Professionals Group business. Recruiting all positions, at all levels, into biotechnology, medical devices, pharmaceutical and scientific companies. For more pharmaceutical or medical related job opportunities visit www.pmpconnect.com. For other healthcare related job opportunities visit www.hpgconnect.com