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Job Description
📋 Description Lead medical writing on complex publications and regulatory documents for filings and dossiers. Collaborate with cross-functional teams (Regulatory, PK, Toxicology, Data Management, Publishing) Mentor junior writers and recommend process improvements to writing systems. Translate scientific data into audience-appropriate formats for journals and submissions. Coordinate reviews, approvals, and audit responses with Regulatory Quality Assurance. 🎯 Requirements Bachelor's degree in English/Communications with science background or Life Science with writing 3-4 years in medical writing or related areas; AMWA certification preferred. Expert knowledge of US/international regulations for scientific publications and submissions. Strong editing/writing skills, attention to detail, and ability to work cross-functionally. Proficiency with journal/congress requirements, ICH guidelines, and electronic submission standards. Experience with eCTD, COSMOS, and electronic document management systems. 🎁 Benefits Competitive compensation range related to location. Comprehensive benefits package including PTO and 401(k). Eligibility to participate in long-term incentive programs.
