Senior Manager, Medical Information jobs in United States
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Nuvalent, Inc. · 17 hours ago

Senior Manager, Medical Information

Nuvalent is an exciting early-stage company focused on developing selective medicines for cancer patients. The Senior Manager, Medical Information will ensure the quality and accuracy of promotional and non-promotional materials while collaborating with cross-functional teams to maintain medical standards and compliance.

BiotechnologyLife ScienceTherapeutics

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

Qualification

PharmDMedical Review experienceScientific literature evaluationMedical writingOncology experienceMicrosoft productsVeeva VaultProblem-solving skillsInterpersonal skillsDetail-oriented

Required

PharmD, PhD, MS, BS, or other clinically oriented healthcare-related degree with appropriate experience
2+ years of experience in working in a Medical Review role in the pharma industry
2+ years of experience in scientific/medical literature identification and evaluation
1+ years of experience in medical writing
Experience with Microsoft products and familiarity with Veeva Vault
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

Preferred

Experience with Microsoft products and familiarity with Veeva Vault
Solid tumor oncology experience
Product launch experience

Benefits

Medical, dental, and vision insurance
401(k) retirement savings plan
Generous paid time off (including a summer and winter company shutdown)
Comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey

Company

Nuvalent, Inc.

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Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Funding

Current Stage
Public Company
Total Funding
$1.82B
Key Investors
Bain Capital Life SciencesDeerfield
2025-11-18Post Ipo Secondary· $500M
2024-09-16Post Ipo Equity· $575M
2023-10-16Post Ipo Equity· $300M

Leadership Team

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James Porter
CEO
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Alexandra Balcom
Chief Financial Officer
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Company data provided by crunchbase