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:
Nuvalent is seeking a highly-motivated, results-oriented team member to join our growing organization as Associate Director, Medical Writing. This role, which will report to the VP, Clinical Development, will partner with departmental leadership to strengthen Nuvalent’s medical writing capabilities and quality standards as well as leading various medical writing projects across Nuvalent’s growing clinical pipeline.
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.
• Prepare and finalize clinical documents such as study protocols, investigator's brochures, informed consent documents, clinical study reports, and clinical sections of briefing documents, regulatory responses, and other submissions.
• 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.
• 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.
• Ensure consultant writers are trained on Nuvalent medical writing processes and provide peer review of deliverables as needed.
• Maintain and apply knowledge of the industry, company, and regulatory guidelines.
Competencies:
• 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:
• At least 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.
• 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 “no-reply@greenhouse.io” 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.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
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