Specialist I, HGR Management (FSP
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were 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
Required Experience:
IC
Key Skills
- General Insurance
- Corporate Sales
- Cost Estimation
- Benefits & Compensation
- Heavy Equipment
- AC Maintenance
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
