MMS
Clinical Strategy & Execution • Regulatory Affairs and Submissions • Clinical Programming & Biostatistics • Data Management • Clinical Trial Disclosures
Principal Medical Writer
August 30, 2023
MMS
Clinical Strategy & Execution • Regulatory Affairs and Submissions • Clinical Programming & Biostatistics • Data Management • Clinical Trial Disclosures
Description
• Under minimal supervision, critically evaluate, analyze, and interpret the medical literature • Write and edit clinical development documents • Complete writing assignments in a timely manner • Practice good internal and external customer service • Highly proficient with styles of writing for various regulatory documents • Interact directly and independently with clients to coordinate projects • Contribute substantially to, or manage, production of interpretive guides • Take ownership of a given assignment • Mentor medical writers and other members of the project team • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus • Experience with orphan drug designations and PSP/PIPs a plus
Requirements
• Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field • At least 6 years of previous regulatory writing experience • Substantial Oncology experience • Substantial clinical study protocol experience, as lead author • Experience leading and managing teams while authoring regulatory documents • Experience in regulatory submissions • Understanding of clinical data • Excellent writing skills • Excellent organizational skills and the ability to multi-task • Expert in MS Word, Excel, PowerPoint, and related word processing tools • Experience being a project lead or managing a project team
Benefits
• MMS is an innovative, data-focused CRO • Strong industry experience and technology-enabled services • 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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