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 BI 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
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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