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MMS
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  • Senior Director, Biometrics  

    - Nashville
    Job DescriptionJob DescriptionAbout MMSAre you looking to join a compa... Read More
    Job DescriptionJob Description

    About MMS

    Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

    Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

    This would be a full-time role, working remotely.

    Job Responsibilities:Has high level knowledge of drug development as it pertains to biometrics.Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.Understands the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of Power BI for dashboard development or use of external SharePoint).High technical level, Subject Matter Expert in biometrics; willing to guide others in a variety of biostatistical techniques.Proficient in the understanding of regulations and guidance as they pertain to data centric deliverables; mentors others and advises on MMS on industry trends and technologies.Ability to define/bring new methods, tools and solutions to meet the needs of internal and external stakeholders and teams.Proficient in conducting peer reviews for others and validation of project deliverables within the team.Maintains a strong understanding of the latest industry trends and technologies with regard to Biometrics.Job Requirements: College graduate in statistics discipline or related field, masters or PhD preferred, or many years of related experience.Minimum of 12 years’ experience in Biometrics or similar field required.Ability to anticipate and effectively resolve potential problems with client demands.Demonstrates managerial skill and experience.Proficiency with MS Office applications.  Hands-on experience with clinical trial and pharmaceutical development preferred.  Good communication skills and willingness to work with others to clearly understand needs and solve problems.   Excellent problem-solving skills.  Good organizational and communication skills.  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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  • Principal Regulatory Strategist (CRO/Pharma Industry) - Remote  

    - Nashville
    Job DescriptionJob DescriptionAre you looking to join a company where... Read More
    Job DescriptionJob DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

    Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

    This would be a full-time role, working remotely.

    Responsibilities:Provide consulting and advisory services for complex regulatory issues or projects.Author and maintain documentation as required to sustain regulatory compliance. Provide senior technical review for complex regulatory projects.Provide cross-functional team leadership and management of multiple stakeholders across diverse projectsConduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.Participate in project teams and provide expertise on related regulatory matters.Clearly and accurately conveys information to peers, supervisors, and other stakeholders.Participates in in implementation of new/updated operational strategies to comply with new/updated policies and recommendations.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.).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).Expert knowledge of regulatory principles and concepts. Reputation as experienced leader with evidence of sustained performance and accomplishments.Proficiency with MS Office applications.          Hands-on experience with clinical trial and pharmaceutical development preferred.        Good communication skills and willingness to work with others to clearly understand needs and solve problems.Excellent problem-solving skills.          Good organizational and communication skills.          Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.
     

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany