Address
Form of workDue to increase in requirements within the R&D Group, an opportunity has now arisen for a R&D Document Associate with a Virology background to provide support in preparing regulatory documentation for global product portfolio including developmental to commercial phases of products lifecycle.
About the Opportunity:
Key responsibilities include the following:
- Create templates for study & regulatory documentation for CMC dossier, R&D reports.
- Generate technical reports for regulatory submissions & prepare regulatory CMC sections.
- Prepare regulatory CMC sections including developmental to commercial phases of products lifecycle.
- Draft SOP, policy & work instruction documents for R&D department.
- Monitor regulatory developments & advise management/key stakeholders on the potential impact of regulations on the organization.
About You:
The successful candidate will have the following skills & experience:
- Bachelor degree or post graduate degree in Life Sciences.
- Sound industry experience in pharmaceutical, medical device, biotech.
- Minimum 3 years regulatory experience in the pharmaceutical industry.
- Virology background highly desirable.
- Strong scientific technical writing skills.
- Demonstrated ability to work across sites and across international teams.
- Excellent interpersonal & communication skills.
- Strong relationship building skills & the ability to influence key global stakeholders.
Culture & Benefits
This is an Excellent Long Term Contract Opportunity for a R&D Document Associate with a Virology background to join a global pharmaceutical organisation & be involved in scientific regulatory documentation work on a global scale.
How to Apply
To apply for this opportunity, please click on the APPLY NOW button and forward your CV in MS Word.
For confidential discussion, please contact Sue Campbell on 0417 994 *** or Maria Julienne on 0491 694 ***.
NB - Only shortlisted candidates will be contacted.
