Principal Medical Writer

August 30, 2023

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MMS

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Clinical Strategy & Execution • Regulatory Affairs and Submissions • Clinical Programming & Biostatistics • Data Management • Clinical Trial Disclosures

501 - 1000 employees

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

💰 Private Equity Round on 2022-06

Description

• Critically evaluate, analyze, and interpret medical literature • Write and edit clinical development documents • Maintain timelines and workflow of writing assignments • Interact with clients to coordinate projects • Mentor medical writers and project team members • Contribute to the production of interpretive guides • Take ownership of assignments • Practice good internal and external customer service

Requirements

• Bachelor's, Masters or PhD Degree in scientific, medical, clinical discipline or related field • Minimum 6 years of previous regulatory writing experience • Substantial Oncology experience • Experience leading and managing teams • Proficiency in MS Word, Excel, PowerPoint • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines • Familiarity with orphan drug designations and PSP/PIPs is a plus

Benefits

• Competitive salary • Comprehensive health benefits • Retirement savings plan • Flexible work hours • Professional development opportunities