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Senior Transparency Specialist

Company: MMS
Location: Canton
Posted on: April 5, 2021

Job Description:

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 or follow MMS on LinkedIn.

Roles & Responsibilities:

  • Responsible for efficiently providing high-quality transparency deliverables (Plain Language Summaries [PLSs]) that are suitable for lay audiences
  • Write documents independently, with skill and proficiency
  • Proficient in reviewing, interpreting, and summarizing Clinical Study Reports; patient Informed Consent Forms; and data tables, listings, and graphs and using as source material for PLSs
  • Maintain a strong understanding of regulations and guidances as they pertain to PLSs; ensure deliverable timelines are compliant with regulatory timelines
  • Work collaboratively with graphics specialist to design graphics needed to convey key scientific concepts for lay audiences
  • Communicate directly with clients and ensure projects are completely in a timely fashion
  • Serve as Project Lead for client accounts and dessimate knowledge of processes to MMS team
  • Proficient with client processes and guidances
  • Develop comment resolution logs as needed; communicate important decisions to team; manage revisions
  • Address client, lay reviewer, and health authority comments during document lifecycle and provide value-added suggestions
  • Implement and validate Quality Control (QC) findings in compliance with company processes
  • Assume responsibility for quality and integrity of documents and review output of other staff to ensure consistency in writing across programs
  • Conduct thorough self-review of deliverables prior to release to client
  • Demonstrate extensive knowledge of departmental processes
  • Bring forth ideas and opportunities for improvements
  • As applicable, maintain a strong understanding of transparency systems and tools, performing UAT when needed
    Service Management:

    • Follow processes related to service management as appropriate (e.g. strategy, design, transition, support, etc.).
    • Manage deliverable risks and timelines
    • Effectively manage/prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time
      Customer Management (Internal and External):

      • Manage day-to-day customer interaction
      • Develop lasting relationships with customer personnel that foster customer ties
      • Set and manage customer expectations
      • Anticipate and understand customer's needs and preferences and be able to provide solutions to customer's needs
      • Develop deliverables according to customer specifications

        Requirements:

        • Bachelor's Degree in a scientific, medical, or clinical discipline or related field is required; Master's or PhD preferred, or many years of related experience if less than a Bachelor's
        • At least 3 years of previous transparency experience
        • Hands-on experience with clinical trials and pharmaceutical development preferred
        • Effective problem-solving and data analysis skills
        • Experience in the pharmaceutical or CRO industry highly preferred
        • Familiarity with current ISO 9001 and ISO 27001 standards preferred.
        • Familiarity with 21 CFR Part 11, FDA, and GCP requirements
        • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
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Keywords: MMS, Canton , Senior Transparency Specialist, Other , Canton, Michigan

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