Principal Medical Writer

Job Description

Critically assess and interpret medical literature to identify primary resource materials, focusing on study design, statistical significance, scientific rigor, and absence of bias. Author and refine clinical development documents, including clinical protocols, investigator brochures, clinical study reports, consent forms, integrated safety and efficacy summaries (Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents), presentation materials, and publications for medical journals. Ensure timely completion of writing assignments, maintain project timelines and workflow, and provide excellent internal and external customer service. Demonstrate proficiency in writing styles for regulatory documents and expertise with client templates and style guides. Independently engage with clients to coordinate project facets, showcasing strong communication skills. Contribute to or manage the creation of interpretive guides. Take ownership of assignments, proactively consulting team members for information or guidance. Mentor medical writers and other project team members involved in the writing process.

Qualifications

1. Bachelor’s, Master’s, or PhD Degree in a scientific, medical, or clinical discipline, or a related field, is required, along with at least 6 years of regulatory writing experience; a Master’s or PhD is preferred. 2. Extensive experience as the lead author of clinical study protocols is essential. 3. Experience leading and managing teams while authoring regulatory documents within aggressive timelines is necessary. 4. Experience with regulatory submissions (clinical study reports) presented to regulatory authorities is advantageous. 5. A solid understanding of clinical data is crucial. 6. Exceptional writing skills are a fundamental requirement. 7. Excellent organizational skills and the capability to multitask are essential. 8. Proficiency in MS Word, Excel, PowerPoint, and related word processing tools is a must. 9. Experience in a project lead role or managing a project team is beneficial. 10. A strong grasp of federal regulations, Good Clinical Practices, and ICH guidelines is a plus. 11. Experience with orphan drug designations and PSP/PIPs is also beneficial.

Benefits

- Great Place to Work certified organization - Supportive, innovative team environment - Exceptional culture and industry-best employee retention rate