HGRAC Specialist

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Accountabilities:

• Support CTM with the preparation of HGR submission dossier 

• Prepare and complete HGR application forms in internal and regulatory authority systems in compliance with client SOPs, ensuring high quality and regulatory standards 

• Support communication with HGR regulatory authorities on inquiries and consultations, and assist in identifying appropriate resolutions 

• Support conducting quality review on all HGR submissions according to HGRAC regulations 

• Regular update for HGR related information 

• Tracker management, documentations archiving 

• Perform other tasks, as assigned or requested 

Minimum Education/Degree Requirements* 

Bachelor Degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences. 

Required Capabilities (Skills, Experience, Competencies) * 

• Minimum 1+ years working experience in pharmaceutical industry, ideally with HGR related experience 

• Good understanding of HGR regulations 

• Good understanding of ICH GCP, and related working knowledge and processes in clinical trials 

• Good time management skills, detail oriented, and ability to manage multiple tasks in a high-volume environment with shifting priorities 

• Good communication skills 

• Quick learner, good team player 

• Fluent in reading, writing and speaking English