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