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 Senior Director, Medical Writing, the Associate Director, 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, 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.
Competencies Include:
• 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.
• Detail and process orientated, with excellent project management, problem solving, and organization skills.
Qualifications:
• 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.
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.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from “@nuvalent.com” email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
