Associate Director - Medical Writing

2 days ago

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Nuvalent, Inc.

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Description

• Prepare and finalize clinical documents such as study protocols, investigator's brochures, safety update reports, clinical study reports, marketing authorization submission documents, briefing documents, regulatory responses, and other submissions. • Proactively identify and champion process improvements to enhance Medical Writing efficiencies, capabilities, and quality. Evaluate and establish Medical Writing practices, technologies, and tools consistent with business objectives and regulatory standards. • Lead medical writing projects with respect to timing, scheduling, and tracking. Guide cross‐functional team members on processes. Lead cross-functional document planning and review meetings, supported as necessary by Clinical Development. • Proactively collaborate with cross-functional colleagues (including Clinical Science, Regulatory Affairs, Pharmacovigilance, Biostatistics, Translational Medicine, Biology, and Clinical Operations) to create documents that effectively and clearly describe scientific strategy, research results, and other medical information. • Oversee consultant writers and provide peer review of deliverables as needed. • Maintain and apply knowledge of the industry, company, and regulatory guidelines.

Requirements

• Experience as lead writer for marketing authorization submission documents. • Experience managing writing activities for a marketing authorization submission documents (project or people management). • Advanced degree (preferred) with strong experience in medical writing or related field. • In-depth understanding and familiarity with regulatory standards and best practices relating to development of clinical/regulatory documents. • Excellent interpersonal skills to effectively communicate and collaborate with all levels of the organization. • Oncology experience is preferred.