[Hiring] Regulatory & Site Activation Specialist @Worldwide Clinical Trials

Role Description

As a member of the Regulatory Affairs team at Worldwide Clinical Trials, you will:

• 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.
• 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.

Qualifications

• Organizational and time management skills.
• Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
• Strong written and verbal communication skills to clearly and concisely present information in English and local language.
• Strong ability to handle multiple tasks in a fast-paced and changing environment.
• Proficiency in MS Office applications, including Microsoft Word, Excel, and PowerPoint.
• Strong understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.

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, and other relevant guidance on conducting clinical research.
• Experience in regulatory submissions in Taiwan.
• Multilingualism preferred; working knowledge of English.

Benefits

• Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.