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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

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