Manager - Medical Writing

March 13

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

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Nuvalent, Inc.

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Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. • The Role: Reporting to the Senior Director, Medical Writing, the Manager, Medical Writing will partner with leadership to lead various medical writing projects across Nuvalent’s growing clinical pipeline and strengthen Nuvalent’s medical writing capabilities and quality standards. • 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. • Responsibilities: 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. • Responsibilities: 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. • Responsibilities: 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. • Responsibilities: Oversee consultant writers and provide peer review of deliverables as needed. • Responsibilities: Maintain and apply knowledge of the industry, company, and regulatory guidelines.

🎯 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). • Advanced degree (preferred) • 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. • Oncology experience is preferred.