Band

Level 3

Job Description Summary

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, Novartis SOP and applicable policies.

Job Description

Key responsibilities:

HGRAC Execution

• Act as key contact person to make sure local study teams can successful complete the preparation of HGRAC submission dossier, submit the HGRAC approval application and ensure all type of the HGRAC approval in line with HGRAC policies.

• Proactively negotiate with HGRAC and hospitals to ensure each permit application successful and each batch permit of trial samples to be exported successfully, per the trial plan.

• Maintain each type of HGRAC application related data tracking, as well as the relevant files archiving per the trial plan.

• Proactively work with local study teams to collect the data, address the issues and concerns to respond the internal/external environment change, and to proactively provide the inputs on the sample exportation application process optimization and issues resolution.

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.

Essential requirements:

• Degree in scientific or healthcare is preferred, or equivalent working experience

• Fluent in local language

• Good English

• Minimum 2 years’ pharmaceutical industry experience with 1 year strong experience in clinical research/HGRAC related work

• 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

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences