Regulatory & Site Activation Specialist
W
Worldwide Clinical TrialsClinical research
TaiwanFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Strong written and verbal communication skills to clearly and concisely present information in English and local language both; working knowledge of English.
- Experience
- Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Complete a minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences.
- Have a minimum of three years of clinical research experience, preferably in site activation and/or a regulatory-related function.
- Have previous experience within the pharmaceutical or CRO industry.
- Have thorough knowledge of ICH GCP and other relevant guidance on conducting clinical research.
- Have experience in regulatory submissions in Taiwan.
- Have strong written and verbal communication skills in English and the local language.
- Be proficient in Microsoft Office applications, including Word, Excel, and PowerPoint.
- Demonstrate organizational and time-management skills.
- Be able to plan, strategize, manage, monitor, schedule, and critique.
- Be able to handle multiple tasks in a fast-paced and changing environment.
- Understand country-level cultural norms and local healthcare systems, and be able to develop relationships with local investigators and key site personnel.
Responsibilities
- Liaise with SAR colleagues to plan, organize, compile, progress, track, and submit regulatory submissions on time and to a consistently high level of quality.
- Act as a contact point for translation review of submission documents, including applications, synopses, ICFs, and labels.
- Maintain country-specific patient information sheet and consent form customization text.
- Maintain country-specific drug-labeling information and Country Intelligence Pages.
- Review labels, patient information sheets, diary cards, and other relevant documentation for compliance with ICH GCP and country-specific requirements.
- Make recommendations on relevant documentation.
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