Key Responsibilities:
Experience in validating and maintaining the regulatory information and
Performing xEVMPD submissions via Veeva Vault & EVWEB and tracking the status of Acknowledgements received.
Knowledge of European regulatory framework including structure and
Content of Summary or Product Characteristics (SmPC).
Have fundamental understanding of XEVMPD and IDMP requirements
and regulations.
Knowledge of IDMP, EU Implementation guide and SPOR.
Knowledge of IDMP User Acceptance Testing
Expertise in handling Art.57 QC queries from EMA.
Well aware of service desk communication with EMA for pending
Acknowledgments and other gateway issues.
Well aware of SPOR (PMS, OMS, RMS, and SMS) and PLM.
Assisting operational activities to ensure compliance with regulatory
Obligations including XEVMPD and IDMP.
Awareness regarding DADI/PLM and its relationship between
PMS/xEVMPD.
Knowledge of Microsoft 365 Apps (e.g., Excel, Teams, SharePoint, etc.)
Ability to collect, aggregate and map data from and between different
Documents and systems.
One of the biggest clinical research organizations (CROs) in the world, Parexel offers the whole spectrum of Phase I to IV clinical development services to expedite the delivery of life-saving medications to patients. Our team of more than 21,000 global professionals uses the depth of our clinical, regulatory, and therapeutic expertise to design and conduct clinical trials with patients in mind. By increasing access and participation, we can make clinical research a care option for anyone, anywhere. We collaborate with leading biopharmaceutical companies, up-and-coming innovators, and sites.
Our extensive industry experience and solid performance over the previous 40 years have advanced clinical research in the most challenging areas of healthcare, and our innovation ecosystem provides high-caliber solutions to improve efficiency at every stage of the clinical trial process. Every trial matters because of our exceptional staff, astute observations, and unwavering commitment to operational excellence, which enable us to strive every day to treat patients with dignity and perpetually learn from their experiences.
With Parexel being named "Best Contract Research Organization" by an independent panel for Citeline in November 2023, "Top CRO to Work With" by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey, and the recipient of the 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships, we continue to receive industry recognition for our approach.