inVentiv Health Country Submission Specialist I (CTAA) - Taiwan in Taiwan, Taiwan
InVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With over 7000 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
DYNAMIC ENVIRONMENT. REWARDING CAREER.
Although inVentiv Health Clinical is one of the world’s leading providers of contract drug development services, we recognize you have a choice of where you seek employment. Here’s why inVentiv Health Clinical should be at the top of your list.
You will join a team of individuals who have the desire to excel in their fields, pursue excellence, and develop intelligent solutions by applying their knowledge and experience. Continuing professional development, personal incentive awards, competitive benefits, and opportunities can all be part of your career growth. Our culture is focused on internal communications and mutual respect for each other and our clients, and an absolute commitment to quality in everything we do.
We have great openings and opportunities across the South East Asia Region including; Singapore, Malaysia, Taiwan, Thailand and Hong Kong.
Title Country Submission Specialist I (CTAA) - Taiwan
Job ID 14098
Priority 1 - High
Conduct research of local requirements for documentation of IRB/EC submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal.
Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
Complete review of essential documents following Essential Document Checklist QC.
Review translations of regulatory documents.
Provide regular local status updates to SSU Project Lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
· Support other departments as necessary
Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues
Complete assigned training programs and applying learning.
Perform administrative tasks.
Bachelor’s degree or RN in a related field orequivalent combination of education, training and experience
6 months clinical research experience with relevant study start-up experience preferred
Ability to learn and follow task-specific procedures, be attentive to detail and place importance on accuracy of information
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Strong organizational skills
Ability to effectively interact with project team(s) and effectively communicate in English and in the local language of the country where located
Ability to work independently in a fast-paced environment
Must demonstrate good computer skills
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Occasional travel may be involved
Country Taiwan [TW]