Description
Role Overview
The Senior Manager, Medical Information is a key member of the Medical Affairs team responsible for leading high-quality medical information services, supporting medical excellence initiatives, strengthening Medical Affairs operational processes, and contributing to scientifically accurate, balanced, and compliant medical content.
This role serves as a senior subject matter expert for medical information and content across Medexus' products. The individual will manage and/or support medical information inquiry processes, standard response development, MLR review activities, content generation, vendor/call center oversight, metrics reporting, and continuous improvement initiatives. The role requires strong scientific judgment, excellent medical writing skills, operational discipline, cross-functional collaboration, and a deep understanding of medical, regulatory, legal, and compliance requirements.
Key Responsibilities
Medical Information- Serve as a senior Medical Information lead for Medexus products, ensuring timely, accurate, balanced, and scientifically rigorous responses to unsolicited medical information inquiries from healthcare professionals, payers, managed care organizations, and internal stakeholders.
- Provide oversight and support for call center/vendor activities, including inquiry triage, escalation management, quality assurance, and process improvement.
- Develop, maintain, and update medical information resources, including standard response letters, FAQs, product knowledge databases, backgrounders, clinical summaries, and other scientific response materials.
- Conduct advanced literature searches and critically appraise scientific and clinical data to support medical information responses, internal education, and content development.
- Monitor new literature, labeling updates, guidelines, compendia, congress data, and relevant external developments to ensure medical information resources remain current and scientifically accurate.
- Support medical information booth coverage at congresses and external meetings, as needed.
- Contribute to inspection/audit readiness by maintaining appropriate documentation, version control, approval records, and process adherence.
MLR, Medical Review, and Content Generation- Serve as a medical reviewer for promotional and non-promotional materials through Medical, Legal, Regulatory review committees, ensuring content is scientifically accurate, medically appropriate, balanced, and aligned with approved labeling and applicable requirements.
- Review promotional, educational, training, payer, field medical, and scientific materials for medical accuracy, appropriate substantiation, consistency, and fair balance.
- Develop and/or review medical content, including SRLs, FAQs, slide decks, training materials, scientific narratives, disease-state content, product summaries, compendia support documents, dossiers, and internal medical resources.
- Collaborate with Medical Affairs, Regulatory, Legal, Commercial, Market Access, Pharmacovigilance, Quality, and external vendors to ensure medical content is accurate, compliant, and fit for purpose.
- Support claims development and substantiation by identifying, evaluating, and documenting appropriate scientific evidence.
- Ensure medical content reflects the highest level of available evidence and is updated proactively when new data, label changes, guidelines, or safety information emerge.
Cross-Functional Collaboration and Strategic Support- Provide medical/scientific input to cross-functional teams and workflows to support product strategy, lifecycle management, launch readiness, field medical needs, dashboards, commercial review, and stakeholder education.
- Translate complex clinical and scientific information into clear, accurate, and audience-appropriate content for internal and external stakeholders.
- Collaborate with Medical Affairs colleagues to identify emerging scientific insights, evidence gaps, and opportunities for new or updated medical content.
- Support special projects and expanded Medical Affairs functions as needed, including process optimization, internal training, medical planning, scientific communications, and operational excellence initiatives.
Education, Experience, and Skill Requirements- Advanced degree required, PharmD is strongly preferred.
- 3+ years of experience in Medical Information, Medical Affairs, Scientific Communications, or related pharmaceutical/biotech functions.
- Experience reviewing promotional and/or non-promotional materials through MLR medical review, or similar compliance review processes.
- Demonstrated experience developing medical information content, standard response letters, FAQs, scientific summaries, training materials, or other medical/scientific communications.
- Experience with vendor or call center oversight preferred.
- Experience in heme-onc is preferred
- Familiarity with FDA, Health Canada, and other applicable regulatory/compliance expectations for medical information, promotional review, and scientific exchange is preferred. Job Competencies
- Strong scientific acumen and ability to interpret clinical data, statistical analyses, prescribing information, guidelines, and peer-reviewed literature.
- Excellent medical writing, editing, and verbal communication skills.
- Strong understanding of medical information best practices, MLR review principles, scientific exchange, fair balance, and compliance requirements.
- Ability to create clear, accurate, scientifically balanced, and audience-appropriate medical content.
- Strong project management and medical operations capabilities, including prioritization, timeline management, documentation, solution-oriented, being resourceful, and process improvement.
- Ability to work cross-functionally and influence stakeholders across Medical Affairs, Regulatory, Legal, Commercial, Market Access, Quality, and external partners.
- High attention to detail and commitment to quality, accuracy, and compliance.
- Strong analytical skills, including ability to interpret inquiry trends, operational metrics, and content gaps.
- Comfort with digital tools, content management systems, workflow platforms, and emerging technologies, including AI-enabled solutions where appropriate.
- Microsoft Office Suite: Word, Excel, PowerPoint, Outlook,
- Medical information and content management platforms such as Veeva MedComms and PromoVault.
- Virtual collaboration platforms such as Zoom.
Additional Information:
• Base salary range: $140K - $180K
• Remote role with limited travel for team/company meetings
Compensation
$140,000.00 - $180,000.00 per year
