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Clinical Trial Disclosure and Transparency Lead

Company: MMS Holdings Inc.
Location: Canton
Posted on: August 18, 2019

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 www.mmsholdings.com or follow MMS on LinkedIn.Roles & ResponsibilitiesFacilitates the initiation, progression, and completion of all disclosure workflow stepsResponsible for writing protocol and results summarizations and other transparency-related deliverablesPrepares regular study tracking and metric reportsInteracts directly and independently with client to coordinate all facets of transparency projects; expert communicator; builds and maintains strong client contacts and relationshipsStrong understanding of US and global clinical trial disclosure regulatory requirements; assures alignment of regulations with company systems and working practicesProvides business input and testing support for clinical trial disclosures systems and documentation, including defining system requirements and business use cases, UAT test script development and execution, content review of marketing and training materials, and development of user guides. Previous experience with software development preferred but not requiredCreates training exercises; serves as mentor and trains new transparency team membersParticipates in transparency and/or organizational initiativesInitiates SOP updates and provide specifications for transparency systems/tools and process enhancementsAbility to work independently and resolve issuesConfident, positive attitude displayed towards clients and projectsConfidently displays excellent internal and external customer serviceRequirementsBachelor's or Master's degree in scientific or health care field preferred with industry or relevant experience5+ years' experience in transparency field with a minimum of 3 years' experience leading projectsExtensive knowledge of US and global transparency regulatory requirements Excellent verbal and written communication skills, as well as, interpersonal and organizational skillsMust be able to work in an energetic, fast paced environmentMinimal travel required

Keywords: MMS Holdings Inc., Detroit , Clinical Trial Disclosure and Transparency Lead, Healthcare , Canton, Michigan

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