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Requirements College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred. Minimum of 10 years’ experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA and/or EMA) and FDA REMS. Expert knowledge of scientific principles and concepts.
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College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred. Minimum of 10 years’ experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA and/or EMA) and FDA REMS.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
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Identifies new/updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc. Author and maintain documentation as required to sustain regulatory compliance.
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Provide consulting and advisory services for complex regulatory issues or projects. Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
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Participate on project teams and provide expertise on related regulatory matters. Provide senior technical review for complex regulatory projects. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years.
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Comor follow MMS onLinkedIn. Basic understanding of CROs and scientific andclinical data/terminology, andthe drug development process. Hands-on experience with clinical trial and pharmaceutical development preferred.
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Reputation as emerging leader in field with sustained performance and accomplishment. Participates in in implementation of new/updated operational strategies to comply with new/updated policies and recommendations.
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Expert knowledge of scientific principles and concepts. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Good organizational and communication skills.
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Excellent problem-solving skills. Proficiency with MS Office applications. For more information, visitwww. Clearly and accurately conveys information to peers, supervisors, and other stakeholders.
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Excellent problem-solving skills. Proficiency with MS Office applications. For more information, visitwww. Clearly and accurately conveys information to peers, supervisors, and other stakeholders. Powered by JazzHR.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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For more information, visit or follow MMS on. For more information, visit or follow MMS on.
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regulatory affairs public jobs Company: Mms in Wailuku, Hawaii
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