RA Associate I
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
RA Associate II
Seoul, Korea
Overview of the role
- Responsible for logistic managements including
the preparation of submission packages for import permit applications and
custom clearance.
- Responsible for regulatory maintenance
activities including IND amend & notification and annual report of ongoing
studies in accordance with ICH, GCP and all applicable regulations, laws and
other guidelines and ethical standards – within specific timelines and quality
standards; accountable for the dispatch and tracking of submissions to
Regulatory Authority(RA)and communication with MFDS.
- Responsible for co-ordination of translations
and filing of country level related documents.
- Develop and finalize Country Specific
Information Sheets / Informed Consent Forms (SIS/ICFs). Deliver the sponsor
specific training for assigned country level personnel.
- Communication with study team and sponsor(if
needed).
- Perform timely and accurate data entry of
regulatory documents, submission status and maintenance of Country information
in the appropriate clinical trial management system
Role Requirements
- Bachelor’s Degree or higher graduate degree
from the Medical background and/or discipline.
- Working experience in multinational
pharmaceutical companies or CROs (Preferred).
- Experience of logistic activities including
import permit applications (Preferred).
- Experience of MFDS submissions or
notifications (Preferred).
- Knowledge of local regulatory
requirements/guidelines and global standards (Preferred).
- Experience reviewing Informed Consent Forms
and following up with Legal as needed in accordance with the protocol
(Preferred).
- Effective oral and written communication
skills.
- Excellent written and spoken English.
- Competent computer skills
Benefits of Working in ICON
Other than working with a great team of smart
and energetic people, we also offer a very competitive salary and benefits
package that includes an excellent pension scheme, private health care, life
assurance and staff recognition schemes. This varies from country to
country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to
our success. We provide an open and friendly work environment where we empower
people and provide them with opportunities to develop their long term
career.
What’s Next
Following your application you will be contacted
by one of our dedicated recruiters and if successful we will be able to provide
you with more details about this opportunity.
ICON is an equal opportunity employer -
M/F/D/V and committed to providing a workplace free of any discrimination
or harassment.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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