Nuvalent, Inc. - Manager, GMP Quality Assurance
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Requirements
• Bachelor’s degree in biology, chemistry, life sciences field preferred or related experience. • 5+ years of experience working in Quality functions supporting cGMP manufacturing of pharmaceutical products. • Direct experience working with the GMP manufacturing of small molecule products is required • Direct experience working with the GMP manufacturing oversight of small molecule drug substances is a plus • Working knowledge of MS Word, MS Teams, Veeva Quality Docs, SharePoint and Smartsheet is preferred. • Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations is required. • Knowledge of cGMP regulations, practices, and trends pertaining to commercial product manufacturing and testing is preferred. • Travel approximately 15% • Additional Information: • Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. • The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change. • Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.
Responsibilities
• Provides education to HCPs and their staff on payer-specific coverage criteria and documentation requirements to help address access and reimbursement barriers for prescriptions already in progress. Delivers guidance on access support, including processes, forms, payer-related coverage challenges, and the Nuvalent patient financial support programs. • Educate HCP staff on patient support (PS) programs, resources, enrollment processes, and application updates so that they are informed on how to use our PS offerings & status of their patients. • Proactively identify and help to resolve payer, account, and patient access barriers using data-driven insights, dashboards, and cross-functional collaboration. • As the PS & payer landscape subject matter expert, coordinate with specialty pharmacy, PS operations, payer, market access, medical affairs, and other cross-functional colleagues to support patient access. • Triage and resolve patient support related questions and access concerns escalated from field teams, ensuring timely and compliant resolution. Educate and inform regional field facing teams on PS programs, geographical payer nuances, access challenge trends, and program insights. Develop internal and external access tools & training materials. • Develop patient access and reimbursement strategies with cross-functional teams, while monitoring regulatory, payer & industry trends, to proactively & compliantly address access challenges. • Support oversight of patient support programs (financial assistance & non-commercial specialty pharmacy); ensuring accountability for positive customer impact & excellence. Coordinate regularly with PS operations teams on patient case updates and escalate as required. • Competencies Include: • Demonstrated passion for improving patient access and outcomes. • Problem-Solving: Proactive approach to resolving complex access issues. • Analytical Skills: Ability to interpret coverage trends & payer policies to identify barriers and implement solution-oriented strategies to optimize patient access. • Business Acumen: In-depth understanding prior authorization, coding, billing, patient services, and specialty pharmacy processes. • Provider Engagement: Building strong relationships with healthcare providers and office Highly responsive; ability to support escalations outside of local time zone working hours, as needed. • Cross-Functional Collaboration: Partnering with sales, market access, patient services, and medical affairs. Foster a culture of empowerment, collaboration, and a focus on patient impact. • Team Leadership: Proven leadership and conflict resolution skills. Encourage collaboration, innovation, and new ideas while integrating information from various sources. • Clear Communication: Highly effective presentation, communication, emotional intelligence, and facilitation & interpersonal skills.Ability to explain complex reimbursement processes in simple terms. • Process Improvement: Identifying opportunities to streamline reimbursement workflows. • Adaptability: Managing evolving payer landscapes and policy changes.
Benefits
• $125,000—$145,000 USD • 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. • 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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