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.
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.
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 in Global Health & Pharma’s international awards programs for the last three consecutive years.
For more information, visit www.mmsholdings.com or follow MMS on LinkedIn . 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.
Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
Participate on 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 and / or EMA) and FDA REMS.
Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.
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. Powered by JazzHR
Principal Regulatory Strategist (CRO Industry) - Remote
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. Conduct regulatory intelligence gathering to support development of regulatory roadmaps, c...
Project Manager (Traveling)
Per S Group is seeking a Traveling Project Manager for our client, a distinguished construction and engineering leader known for delivering top-quality projects across various sectors focusing on innovation and sustainability. Lead all projects construction projects in the automotive (plants) and/or...
Senior Buyer & Project Manager
Job Title: Procurement Certificatton Engineer .We are a leader in the automatton and manufacturing industry, renowned for our excellence in.Our commitment to technological.We value teamwork, dedicatton, and continuous improvement, ensuring our products maintain their competitive edge globally.As a P...
Data Quality Analyst
You will work closely with our DataOps team, Data Owners, and Data Stewards to establish, implement, and sustain data quality standards and procedures. Oversee data governance, data profiling, and ETL processes with tools like SAP BODS, SAP SLT, SSIS, and SAP CPI to ensure data quality and accurate ...
Project Manager
Advanced-level IT project manager, capable of managing the largest, most mission-critical enterprise technology projects. Defines project scope, objectives, and cost estimates in project lifecycle and definition documents. Develops detailed project execution plans, schedules, project estimates, reso...
Electrical Project Manager
Electrical Senior Project Manager. Senior Project Manager (Electrical). They specialize in complex projects that are multi-phased design/build and have an impressive portfolio of impressive projects nationwide. Communicate with operations teams and customers to define the project scope, and/or analy...
Graphic Designer/ Customer Service Representative
Fastsigns of Southfield is hiring for a Full-time Graphic Designer to join our team. A Successful FASTSIGNS Graphic Designer Will: . Ideal Qualifications for FASTSIGNS Graphic Designer:. Create computer-generated full-color graphics and/or vinyl output that can be printed and mounted to a substrate ...
BMC - Construction Project Manager (Travel) - Southfield, MI
Barton Malow Company is seeking a Project Manager to join our renewables team on projects throughout the state of Michigan. Manage and assist in internal and subcontractor: estimates, prepare and review project proposals or plans to determine and establish a time frame, work plan, funding limitation...
Project Manager
Preparation of proposals on projects with subsequent project management responsibilities including budgeting, scheduling, directing employees, prioritizing multiple projects and deadlines, and communicating with superiors and clients on small to medium-size projects. At Spicer Group, Project Manager...
UX Designer
The Criteo Product Design department is composed of skilled teams of UX Designers, UI Designers, Researchers, and Writers. As a UX Designer on the Retail Media team, you’ll help craft user experiences that enable brand marketers and retailers to set up and deliver relevant and insightful advertising...