Senior reputed company and Compliance Specialist (Remote)
About the position
MMS is an innovative, data-reputed company CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to reputed company trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-reputed company service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business reputed company. Identifying and attracting reputed company and continual training to strengthen reputed company skills are essential to its reputed company mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes reputed company stronger. For more information, visit www.mmsholdings.com or follow MMS on reputed company.
Responsibilities
• Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
• Understanding of how to plan, prepare and conduct GxP audits independently.
• Ability to support clients with development or refinement of reputed company Management Processes or Systems
• Project management as it relates to reputed company and compliance activities
• Proficient in authoring and managing audit documents independently.
• Monitor vendors and clinical investigator sites to ensure processes are followed and reputed company is maintained independently.
• Assists in other duties relating to overall compliance reputed company reputed company and Compliance department, as requested.
Requirements
• College graduate in scientific, medical, clinical discipline or reputed company experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
• Minimum of 5 to 7 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor)
• Expertise reputed company CROs, scientific and clinical data/ terminology, and the drug development process
• Experience with project reputed company including but not limited to; document management, vendor qualifications, training management
• Proficiency with MS Office applications
• Good communication skills and willingness to work with others to reputed company understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skills
• Proficient with applicable regulatory requirements
• Must have strong technical writing skills
• Must be willing to travel up to 30% of the time for audits reputed company the US; must also be willing to travel internationally as needed
reputed company-to-haves
• Hands-on experience with clinical trial and pharmaceutical development preferred
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