Specialist, Regulatory & Site Activation
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Job Description
Specialist in Regulatory & Site Activation at Worldwide Clinical Trials in Australia. Responsible for driving regulatory submissions with a focus on quality and compliance.
Responsibilities:
- 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.
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 and Singapore preferred
- Multilingualism preferred; working knowledge of English.
Benefits:
- Flexible working arrangements
- Professional development opportunities
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