Job Information
MMS Holdings Inc. Senior Regulatory Operations Specialist in Pittsburgh, Pennsylvania
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
In the project lead role:
Prepares and compiles documents for submission to regulatory health authorities
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
Performs quality control checks to regulatory submissions to ensure compliance with ICH and company defined standards
Maintains regulatory submission tracking log and imports archival submissions into company document management system
Creates, formats, and reviews documents and references to meet style guide and submission ready requirements
Maintains submission project plans and tracks components
Conducts self-review of deliverables prior to release to clients
Maintains working knowledge of applicable regulations and ICH guidance documents; reviews proposed changes to identify process impact and supports implementation
Leads improvement efforts to departmental processes and recommends efficiencies
Demonstrates strong internal and external leadership skills
Complies with Document and Record Control Procedures
Complies with applicable Quality Management System and Information Security Management Systems policies and procedures; contributes input to updates
Assists IT with electronic document management and publishing systems testing to verify and validate operation and performance
Provides support and training to end users as needed on company style guide, template usage, and general processes that support regulatory submissions
Leads effort to create training materials and exercises; mentors new regulatory operation colleagues
Travels to client sites as necessary
Job Requirements:
Graduate degree preferred, or relent experience
5+ years of experience in the Pharmaceutical, Biotech or CRO industries
Prior publishing experience required
Proficiency with MS Office and SharePoint applications
Self-motivated with developed skills in multi-tasking, attention to detail and follow-through
Excellent organizational, project coordination, and communication skills
Ability to multi-task efficiently