MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn (https://www.linkedin.com/company/mms-holdings-inc-/) .
Roles & Responsibilities
Practices excellent internal and external customer service
Prepares and compiles documents for submission to regulatory health authorities under the direct supervision of the Project Lead
Publishes regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards by creating bookmarks, hypertext links, etc. using eCTD publishing tools and document management systems under the direct supervision of the Project Lead
Maintains submission project plans and tracks components under the direct supervision of the Project Lead
Performs quality control checks to regulatory submissions to ensure compliance with ICH and company defined standards under the direct supervision of the Project Lead
Maintains regulatory submission tracking log and imports archival submissions into company document management system under the direct supervision of the Project Lead
Creates, formats, and reviews documents and references to meet style guide and submission ready requirements under the direct supervision of the Project Lead
Conducts self-review of deliverables prior to release to client
References applicable regulations and ICH guidance documents to complete daily work
Job Requirements
Bachelor?s degree or equivalent experience
Proficiency with MS Office and SharePoint applications
Self-motivated with developed skills in multi-tasking, attention to detail and follow-through
Good organizational and communication skills
Ability to multi-task efficiently