Submission Specialist

2 weeks ago

Sydney, Australia PSI CRO Full time

Company Description

We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.

**Job Description**:
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

**Your role**:

- Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
- Manage safety reporting to authorities
- Deliver regulatory training to project teams
- Assist with feasibility research and business development requests

**Qualifications**:

- College/University degree or an equivalent combination of education, training and experience
- 2-3 years experience with clinical trial submissions preferably in CRO or pharmaceutical environment in Australia and New Zealand (advantage)
- Solid knowledge of GCP, national and international regulations
- Excellent interpersonal skills and work in a dynamic team environment

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