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Jobs/CRO Role/Nuvalent, Inc. - Senior Manager, Medical Information
Nuvalent, Inc.

Nuvalent, Inc. - Senior Manager, Medical Information

Remote - Cambridge, MA, USA *$150k - $150k2mo ago
RemoteSeniorNAInsurancePharmaceuticalsManufacturingCROSenior Community ManagerMedical Services ManagerClinical DirectorRisk ManagementPharmacovigilanceMBAClinical TrialsCRO

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Requirements

• Bachelor's degree is required. • 8+ years of biopharma experience, including. 3+ years of oncology field reimbursement manager (FRM) / or access reimbursement manager (ARM) experience with established relationships at major oncology centers across the country. • Extensive experience in oral / specialty oncology access, rare disease launch, program implementation, and payer navigation. • Demonstrated excellence in customer engagement. • Previous experience supporting HCP staff through complex reimbursement barriers, prior authorizations, appeals, and providing education. • Knowledge of all national health insurers (commercial & government) including billing/coding. • Highly organized, team player, excellent communicator, problem solver, and presenter. • Able to work effectively & autonomously through ambiguity. • All activities must comply with HIPAA, OIG, FDA regulations, and Nuvalent policies. This is a non-promotional role. • Previous experience in a clinical role, NSCLC, Patient Services program oversight, & vendor management preferred. • Prior Authorization Certified Specialist preferred. • Willingness to travel domestically up to 20% (customer engagements, internal & vendor meetings). • Additional Information: • Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. • The targeted salary range below 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

• Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations • Determine if promotional messages and medical statements are appropriately supported by data • Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking • Remain current on regulations and best practices within the industry • Maintain ongoing communication with Medical Leads to ensure materials are aligned to medical strategy • Demonstrate knowledge of disease area, product labeling, and regulatory guidance • Maintain therapeutic area and product knowledge through ongoing assessment of relevant literature, treatment guidelines, and internal and external data sources • Conduct literature searches in order to ensure that the most current and appropriate literature is cited in the materials • Support the development and updates of Medical Information Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and other Medical Information materials in order to ensure complete, accurate, balanced, and referenced materials are available to respond to unsolicited requests for scientific information in a timely manner • Support the development and updates of scientific Medical Affairs materials (e.g., decks, clinical trial flyers, medical exhibit materials, etc.) • Support the development of regulatory compliance processes, including training documents, standard operating procedures, work instructions and other supporting process documents • Support completion of quality review of medical information cases and, as necessary, ensure correction and provide feedback/retraining • Support handling of inquiries escalated to the internal Medical Information department by providing timely responses to unsolicited inquiries • Assist in recognizing, collecting, and ensuring the appropriate forwarding of safety/adverse event and/or product quality information according to FDA guidelines and company policies • Attend external medical conferences and staff the Medical Affairs booth as needed • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. • Competencies Include: • Knowledge of FDA regulations relevant to drug promotion and dissemination for medical and product information • Effective oral, written, and interpersonal skills, ability to work with a wide range of individuals • Ability to adapt, organize, prioritize, and work effectively independently as well as within cross-functional teams • Detail-oriented • Proven problem-solving and conflict resolution skills

Benefits

• $150,000—$175,000 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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