Established in 1986, Worldwide Clinical Trials is a privately held company and leading provider of clinical-trial research studies. As an employer, the company
Regulatory & Site Activation Specialist
Location
Australia
Posted
17 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory & Site Activation Specialist
Worldwide Clinical Trials
• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality. • May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc. • Maintain country-specific patient information sheet and consent form customization text. • Maintain country-specific drug labeling information and Country Intelligence Pages. • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.
Job Requirements
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences
- Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function
- Previous experience within the pharmaceutical/CRO industry.
- Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research.
- Experience in regulatory submissions in Australia
- Multilingualism preferred; working knowledge of English.
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
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