Manager, Medical Writing

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as their Manager, Medical Writing. Reporting to the Senior Director, Medical Writing, you will lead and manage various medical writing projects across Nuvalent’s clinical pipeline. You will be responsible for preparing clinical documents, improving medical writing processes, and collaborating with cross-functional teams. This role requires strong leadership, communication, and medical writing expertise. Success in this position demands a deep understanding of regulatory standards and the ability to manage multiple projects effectively. The ideal candidate will possess advanced medical writing experience and a strong understanding of oncology.

Requirements

• Experience as lead writer for clinical and or regulatory documents
• Experience independently managing writing activities for clinical and or regulatory documents (project and people management)
• 3-5 years’ experience in clinical and or regulatory medical writing
• 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
• Strong written/verbal communication skills
• Ability to interpret, summarize, and present statistical and medical information
• Meticulous attention to detail to ensure accuracy and consistency in all documents
• Ability to work in a collaborative environment and build effective working relationships across the organization
• Detail and process orientated, with demonstrated problem solving, and organization skills
• Ability to manage multiple projects, timelines, and deadlines effectively
• Ability to lead and mentor a team of writers, providing guidance and support for their professional development

Responsibilities

• Prepare and finalize clinical documents such as study protocols, investigator's brochures, safety update reports, clinical study reports, 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

Preferred Qualifications

• Advanced degree
• Oncology experience