HGRAC Specialist

As a HGRAC you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• Responsible for HGRAC submission which focus on interpretation for HGRAC policies and document collection, submission, tracking and archiving.
• Responsible for Clinical trial Registration (CTR) platform registration which focus on interpretation for CTR platform registration policies and document collection, submission, tracking and archiving.
• Compliance with local regulations, GCP, SOP and applicable policies.

What you will be doing:

HGRAC Execution• Act as key contact person to make sure local study teams can successful complete thepreparation of HGRAC submission dossier, submit the HGRAC approval application andensure all type of the HGRAC approval in line with HGRAC policies. • Proactively negotiate with HGRAC and hospitals to ensure each permit applicationsuccessful and each batch permit of trial samples to be exported successfully, per thetrial plan.• Maintain each type of HGRAC application related data tracking, as well as the relevantfiles archiving per the trial plan.• Proactively work with local study teams to collect the data, address the issues andconcerns to respond the internal/external environment change, and to proactively providethe inputs on the sample exportation application process optimization and issuesresolution.

CTR platform registration

• Work as the registrant of CTR platform to make sure local study successful complete CTR platform registration in line with local regulations and Novartis SOP. • Support line functions complete the registration form.• Act as key contact person with CDE.

You are:

Experience/Professional requirement:minimum 3-4 years pharmaceutical industry experience with 2 years strong experience in clinical research/HGRAC related work

Competencies:

• Proven ability to manage teams and complex communication locally and in the global organization.• Able to work in a matrix organization• Ability to work under pressure• Strong Interpersonal skills• Strong leadership skills• Working experience in a global team, team player• Displays innovative ideas and solutions• Highly proficient in negotiation skills• Highly effective in influencing others Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.