Specialist I, HGR Management (FSP） at Parexel

Beijing, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

16 Jun, 26

Salary

0.0

Posted On

18 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

HGR Submission Dossier Preparation, HGR Application Forms Completion, Regulatory Authority Communication, Quality Review, HGRAC Regulations Compliance, Tracker Management, Documentation Archiving, Time Management, Detail Oriented, Multitasking, Communication Skills, Quick Learner, Team Player, English Fluency

Industry

Pharmaceutical Manufacturing

Description

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 a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The Specialist I will support the CTM with preparing HGR submission dossiers, completing application forms in compliance with SOPs, and managing communication with regulatory authorities regarding inquiries. Responsibilities also include conducting quality reviews on submissions and maintaining HGR-related information trackers and archives.