Associate Director, Medical Writing

Summary

Join our growing organization as Associate Director, Medical Writing to strengthen medical writing capabilities and quality standards.

Requirements

• At least 10 years of relevant medical writing experience within the pharmaceutical industry
• In-depth understanding and familiarity with regulatory standards and best practices relating to development of clinical/regulatory documents
• Strong written/verbal communication skills
• Ability to interpret, summarize, and present statistical and medical information
• Ability to work in a collaborative environment and build effective working relationships across the organization

Responsibilities

• Proactively identify and champion process improvements to enhance Medical Writing efficiencies, capabilities, and quality
• Prepare and finalize clinical documents such as study protocols, investigator's brochures, informed consent documents, clinical study reports, and clinical sections of briefing documents, regulatory responses, and other submissions
• Proactively collaborate with cross-functional colleagues to create documents that effectively and clearly describe scientific strategy, research results, and other medical information
• Lead medical writing projects with respect to timing, scheduling, and tracking. Guide cross‐functional team members on processes
• Ensure consultant writers are trained on Nuvalent medical writing processes and provide peer review of deliverables as needed
• Maintain and apply knowledge of the industry, company, and regulatory guidelines

Benefits

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law