Sr. RA Associate

"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.