Role Description
The Senior Manager, Medical Information and Medical Capabilities, will report to the Director, Medical Capabilities and will be a critical member of the Medical Affairs team. This individual will provide integral Medical Information & Medical Capabilities support across Nuvation Bioβs pipeline.
You will be responsible for:
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Medical Information
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Serve as an active member of the Medical Affairs team, providing relevant Medical Information insights and metrics to inform the overall strategy.
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Lead the development, review, maintenance, and approval of Medical Information materials, including Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and custom responses.
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Manage Medical Information operations, vendor oversight, budget, and compliance activities.
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Ensure the call center is fully trained on content availability and escalation processes.
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Ensure all MI content is scientifically rigorous, balanced, and aligned with evolving data.
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Partner with Medical Information vendors and cross-functional stakeholders to support medical inquiry responses and compliance adherence.
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Manage Medical Information metrics, quality indicators, and inquiry trends.
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Medical Review and Governance
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Serve as the Medical reviewer within the Medical, Legal, and Regulatory (MLR) review processes.
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Lead medical accuracy review and provide strategic scientific input.
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Collaborate with cross-functional stakeholders to facilitate timely review and approval of materials.
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Support the development and continuous improvement of MLR review processes and best practices.
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Serve as MLR Coordinator for medical affairs content.
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Medical Affairs Capabilities
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Serve as business owner for Medical Affairs website, overseeing content and ongoing optimization.
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Manage operations of IME grant reviews and approvals.
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Support other medical capabilities projects as needed.
Qualifications
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Advanced degree (MD, PhD, PharmD) in a medical or science-related specialty, or significant experience in a scientific field may be considered.
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3+ years of direct experience in Medical Information and MLR in a biotech/pharmaceutical industry required.
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Oncology experience required; experience in lung cancer and/or neuro-oncology preferred.
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Familiarity with Veeva Promomats and Veeva CRM preferred.
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Proven track record of matrix teamwork, timely decision making, and prioritization.
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Exhibits advanced knowledge of Medical Information work and processes.
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Proficiency in medical writing and medical content creation.
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Experience conducting medical accuracy reviews for promotional and medical materials.
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Demonstrated strong verbal, written, and presentation skills.
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Excellent interpersonal and communication skills with attention to detail.
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20% domestic and international travel to headquarters and medical conferences, as needed.
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Ability to work onsite regularly as needed.
Requirements
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Self-directed and motivated with the decisiveness and flexibility necessary to operate successfully in a complex, dynamic environment.
Benefits
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Competitive Base Salary, Bonus, and Equity Plans.
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Unlimited Vacation and 10 Sick Days Annually.
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Excellent Medical, Dental, and Vision Coverage.
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401K with Company Matching.
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And much more!