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. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the VP, Clinical Development, the Director, Medical Writing will provide leadership to the medical writing function and oversee medical writing projects across Nuvalent's growing clinical pipeline. The individual will be responsible for strengthening Nuvalent's medical writing capabilities, efficiency and quality, as well as recruiting and managing medical writing resources.
Responsibilities:
Provide leadership, strategic direction and hands-on oversight for the medical writing function, including resource allocation, process, quality, and timelines.
Recruit, train, develop, and allocate medical writing resources, including outsourcing where necessary.
Proactively identify process improvements to enhance medical writing efficiencies, capabilities, and quality. Evaluate and establish practices, technologies, and tools consistent with business objectives and regulatory standards. Develop and/or streamline operating guidelines, templates, and style guides.
Plan, coordinate, critically review and/or author medical writing deliverables including but not limited to study protocols, investigator's brochures, clinical study reports, and, in collaboration with regulatory colleagues, briefing documents, regulatory responses, and new drug dossiers.
Accountable for quality of medical writing deliverables, with respect to scientific content, organization, accuracy, clarity of presentation, structure, and adherence to regulatory and company guidelines. Ensure effective cross-functional collaboration to accurately and clearly describe scientific strategy, research results, and other medical information.
Competencies:
Detail and process orientated, with excellent project management, problem solving, and organization skills. Capability to manage multiple projects while maintaining timelines.
Ability to work in a collaborative environment and build effective working relationships across the organization. Strong negotiating, conflict resolution and influence skills.
Communicates clearly, concisely, and effectively in both written and oral communications.
Effective leader with ability to foster the development of others. An effective coach/mentor who holds self and others accountable for performance standards.
Ability to interpret, summarize, and present statistical and medical information, including critical review of the work of others.
Qualifications:
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.
Experience managing in-house and external medical writers.
Experience developing and optimizing medical writing processes.
Oncology experience is strongly preferred.
Prior experience in development of New Drug Application/MAA is strongly preferred.
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