Ref #: 33729

Employment type: Permanent - Full-Time

Location: China-Beijing

Posted: 15-Nov-2021

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Overview
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 10%) domestic and/or international.
• To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, GXP and appropriate regulations and guidelines.
• Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
• Undertake all required tasks requested to meet departmental and project goals, as appropriate.

Major Responsibilities and Duties:
• Participate in regulatory and/or clinical trial project teams as required.
• Plan and track designated project activities including financial tracking under supervision Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements.
• Effectively contribute to all the aspects of allocated projects in timely manner including tracking (time and resources), proactive identification of risks, scope change, financial implications and provision of solutions for approval by Directors.
• Specific Regulatory Submission team activities include (but are not limited to) Input into Preparation, compilation and submission of CT /IND, MAA I NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation, medical device documentation , Readability testing Input into label review, translation requirements, fee requirements etc
• Input to the Regulatory Intelligence function IMPD I IB Core Doc review, labeling review for clinical trial applications Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
• Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON Identify issues and address them in a timely manner, including preventive actions.
• Be solution orientated and own the delivery and commitment on behalf of ICON.
• Responsible for timely and accurate completion of assigned projects and for timely identification of issues or the need for change orders.

Qualifications:
Educational Background
Bachelor’s degree or above (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution

Working Experiences and Competencies
• Proven organizational and presentation skills
• Ability to manage multiple tasks and meticulous attention to detail
• Quick learner, good team player
• Excellent written and verbal communication skills
• Good written and spoken English
• Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint and Outlook, etc
• Good knowledge of ICH-GCP, 1-year Experience as CTA, RA, or other roles in the clinical trials is preferable

To be successful in the role, you will have:

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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