ICT Customer Support Officer

Summary about this job

Detail information about job ICT Customer Support Officer. Terms and conditions vacancy

About Bio and Gene:

Bio and Gene Pty Ltd, based in North Sydney, is a privately owned Australian biotechnology company established in 2003 with a view to assist overseas companies commercialise their health and biological products within Australia's robust regulatory framework. 

With roots in the Asia Pacific pharmaceutical industry, we are involved in a range of activities throughout the Australasian region with a particular focus on international pharmaceutical development.

Bio and Gene manages a diverse product portfolio within a variety of fields whilst engaging in promising research and trading enterprises across an extensive range of markets. We liaise with recognised regulatory agencies worldwide and utilise robust clinical data to ensure that our projects boast high profitability and a proven track record of success.

Bio and Gene is co-located with health and wellness businesses working across the pharmacy, pro-biotics, medical devices, aged care and disability support sectors. 

Key responsibilities of the role include (but are by no means limited to)

• Responsible to communicate with software vendors to follow up software failure case report, update and upgrade periodically.
• Be familiar with creating and managing pharmaceutical regulatory submission technologies such as eCTD, CTD, NeeS, IMPD, DMF, ASMF, PIP as well as eCopy.
• Be familiar with the latest changes in eCTD regional standards from TGA, MedSafe (New Zeland), MFDS (South Korea), US FDA, GCC countries and EMA.
• Be familiar with European “General Data Protection Regulation” (GDPR), ICH document granularity guidelines, regional filenames and FDA 21 CFR part 11.
• Be familiar with DMS systems such as BIOVIA, EMC Documentum, Open Text, and Veeva.
• Be familiar with consulting and designing secured shared computer systems for dossier publishing and drug safety monitoring software.
• Troubleshoot skills, issues / faults and liaise with providers to resolve errors.
• Assist with the purchasing, set-up, configuration and delivery of related technologies.
• Interstate or foreign traveling may be required occasionally; a current driver's license will be required to travel to customer sites.
• Represent our brand in annual and well known regional conferences in Australia, South Korea, ... 

Skills and Experiences

• Ability to manage his/her own time and work autonomously; ability to deliver project on time with excellent quality and compliance with the required standards.
• Most have proven experiences working with life science software solutions from well-known software vendors such as Oracle, EXTEDO, Lorenz, eCTD office, ….
• Must have proven experiences with ICT customer support such as software troubleshooting, software bug fixing, software validation, sales and secure software system consultation.
• Must have proven working experiences entering health data and clinical trial CRF into pharmacovigilance database.
• Ability to interact with various stakeholders and tolerate different roles and responsibilities.
• A Bachelor Degree or higher, or at least 5 years of relevant experience.
• Excellent written and verbal communication skills.
• Can do, will do work attitude.

When & what are the salary and hours

• When? As soon as possible.
• Salary? $65K based plus superannuation.
• Hours? 8:30 AM to 5:00 PM. Some after-hours work and on-call after hours will also be required.

How to apply

• You must be an Australian resident to apply for this position.
• To apply please send a CV and expression of interest statement outlining your skills and experience to our email address.