MMS
Clinical Strategy & Execution • Regulatory Affairs and Submissions • Clinical Programming & Biostatistics • Data Management • Clinical Trial Disclosures
Senior Medical Writing Consultant
August 30, 2023
MMS
Clinical Strategy & Execution • Regulatory Affairs and Submissions • Clinical Programming & Biostatistics • Data Management • Clinical Trial Disclosures
Description
• Critically evaluate, analyze, and interpret medical literature • Select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias • Write and edit clinical development documents • Complete writing assignments in a timely manner • Practice good internal and external customer service • Interact directly and independently with clients • Contribute to or manage production of interpretive guides • Mentor medical writers and project team members • Take ownership of assigned tasks
Requirements
• At least 3 years of previous experience in the pharmaceutical industry • 3-5 years of industry regulatory writing and clinical medical writing experience • Bachelor's, Master's, or Ph.D. in scientific, medical, clinical discipline • Substantial Oncology experience required • Substantial clinical study protocol experience required • Experience leading and managing teams with aggressive timelines • Experience in regulatory submissions a plus • Understanding of clinical data • Excellent writing and organizational skills • Expertise in MS Word, Excel, PowerPoint, and related tools • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines • Experience with orphan drug designations and PSP/PIPs a plus
Benefits
• Strong industry experience • Technology-enabled services • Data-driven approach to drug development • Global footprint across four continents • 97 percent customer satisfaction rating • Recognized as a leading CRO in Global Health & Pharma’s international awards programs
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