Job Description

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\xe2\x80\x99s international awards programs for the last three consecutive years. For more information, visit or follow MMS on .

Roles & Responsibilities:

• Experience with development and writing of CMC-related documents (Module 2.3 QOS and Module 3: 3.2.S, 3.2.P, 3.2.A, 3.2.R)
• Strong understanding of regulatory guidances as it applies to CMC submissions (eg, NDAs, MAAs, BLAs, INDs, IMPDs)
• Interpret and analyze quality data related to product characterization, manufacturing process, product and process control, and stability
• Organizational expert within the CMC subject area
• Ability to complete documents according to sponsor\'s format, processes, and according to regulatory guidelines
• Lead projects independently with minimal oversight
• Interpret and analyze applicable CMC data
• Collaborate with cross-functional teams such as safety, nonclinical, clinical, QC, publishing
• Demonstrated ability to lead others to complete complex projects
• Ability to complete documents according to sponsor\xe2\x80\x99s format, processes, and according to regulatory guidelines
• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
• Excellent written/oral communication and strong time and project management skills
• Ability to attend regular team meetings

• BS + in biology or chemistry, or related field, with industry experience within regulatory affairs, laboratory sciences, quality assurance/control
• Knowledge of GMP, ICH guidelines, and applicable regulatory requirements
• 2+ years of pharmaceutical regulatory CMC writing experience
• Strong writing and analytical skills

MMS Holdings