(Sr) ICF Writer - UK

MMS is a CRO that supports pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges.RequirementsAt least 3 years of previous experience in the pharmaceutical industryMust have at least 3-5 years of industry regulatory writing and clinical medical writing experienceIdeal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical disciplineSubstantial informed consent and clinical study protocol experience, as lead author, requiredExperience leading and managing teams while authoring regulatory documents with aggressive timelinesExceptional writing skills are a mustExcellent organizational skills and the ability to multi-task are essential prerequisitesCandidate must be an expert in MS Word, Excel, PowerPoint, and related word processing toolsExperience being a project lead, or managing a project teamStrong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plusNot required, but experience with orphan drug designations and PSP/PIPs a plusOriginally posted on Himalayas