Sr. RA Associate
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
"At ICON, it's our People that set
us Apart"
This is an exciting opportunity to work within a fast paced, busy
environment for a leading global provider of outsourced development services to
the pharmaceutical, biotechnology and medical device industries. ICON Clinical Research is Whole Owned Foreign
Company which founded in 1990 in
Ireland.
We expanded our business from 1995 in APAC region.
Currently we are hiring the
Sr. RA Associate in our Korea team.
Job Description;
-
Responsible for planning the regulatory submission target timeline and the
collation and verification of the submission documentation
-
Responsible for the independent preparation of country level related submission
packages for Regulatory submission including initial IND, IND amend and
notification in accordance with ICH, GCP and all applicable local 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).
-
Responsible for the translation and co-ordination of translations for documents
required for submission
-
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)
-
Act as the main contact with MFDS and follow up the non-official/official queries
from MFDS in a timely manner
-
Perform timely and accurate data entry of regulatory documents, submission
status and maintenance of Country information in the appropriate clinical trial
management system
-
Responsible for the collection and approval of country level critical document
package required for IP Release
-
Attend study team meetings as required (maybe discretionary), including
Kick-Off Meetings which are mandatory
Requirements;
- Bachelor’s Degree or higher graduate
degree from the Medical/science background and/or discipline
- At least 3~5 years of professional experience for
preparation of submission package and regulatory submissions for IND approval
with full understanding of IND submission requirements and activities
- Experience in communicating with MFDS as the main
contact for initial IND, IND amend and notification
-
Experience in developing Country Informed Consent Forms and following up with
Legal as needed in accordance with the protocol.
-
Knowledge of local regulatory requirements/guidelines and global standards,
mainly for IND application
-
Good interpersonal 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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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