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MMS Holdings Inc.
,
London, Greater London
CMC Medical Writer
Overview
Job Description
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn. Roles & Responsibilities: + Experience with development and writing of CMC-related documents + Strong understanding of regulatory guidances as it applies to CMC submissions (eg, NDAs, MAAs, 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 tables, listings, and figures + Collaborate with cross-functional teams such as safety, biostats, pharmacokinetic, and clinical + Demonstrated ability to lead others to complete complex projects + Ability to complete documents according to sponsor?s format, processes, and according to regulatory guidelines + Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment + Organizational expert within the CMC subject area + Excellent written/oral communication and strong time and project management skills + Ability to attend regular team meetings Requirements: + 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 experience + Strong writing and analytical skills