Director, Medical Information, Content & Review

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the Medical Information department and deliver strategic direction across the development of Medical Affairs content, medical reviews, and scientific training.

• Formulate the Medical Information strategy, manage inquiry processes, create scientific response content, conduct literature surveillance, establish policies, maintain quality standards, track metrics, and implement continuous improvement initiatives.

• Supervise Medical Information resources including standard response letters and other scientific response documents.

• Provide strategic and operational management of the outsourced Medical Information contact center, encompassing vendor onboarding, training, budget management, service levels, KPIs, quality assurance, customer experience, compliance, and audit readiness.

• Lead or manage Medical Affairs resources, including Field Medical personnel, scientific presentations, congress materials, training assets, and digital content for medical websites.

• Ensure responses to unsolicited and off-label requests are scientifically accurate, balanced, and compliant.

• Oversee the medical review of non-promotional materials and act as a representative for Medical Affairs in the review of promotional materials.

• Collaborate with Legal, Regulatory, Compliance, Commercial, Medical, Clinical Development, Drug Safety/Pharmacovigilance, Market Access, and other stakeholders for content review and scientific communications.

• Ensure that adverse events, product complaints, and safety-related information are identified, documented, and routed within specified timelines.

• Develop and facilitate Medical Affairs scientific training, including onboarding, disease-state, product, pipeline, and clinical data training.

• Monitor compendia, clinical guidelines, and clinical pathways and lead the submission and communication efforts related to Market Access.

• Analyze Medical Information inquiries and customer interactions to detect trends, knowledge gaps, and actionable insights.

• Stay current with scientific literature, treatment guidelines, therapeutic area advancements, competitive data, and internal clinical data.

• Provide Medical Information, content, review, and training support for product launches, new indications, clinical data releases, congresses, and scientific milestones.

• Create and maintain policies, SOPs, work instructions, and governance processes related to Medical Information and content.

• Manage external vendors and their associated budgets.

• Execute other responsibilities as assigned.

⛳️ Requirements

• A PharmD, PhD, MD, or another relevant advanced scientific or clinical degree is required.

• At least 8 years of pertinent experience in the pharmaceutical or biotechnology industry, with substantial experience in Medical Information.

• Proven experience in developing and maintaining Medical Information content, including scientific response documents.

• Demonstrated expertise in Medical Affairs content development and the ability to translate complex scientific and clinical information into clear, accurate, and audience-appropriate scientific communications.

• Experience in performing medical/scientific reviews of non-promotional materials and serving as a representative for Medical Affairs in promotional review processes.

• Strong grasp of Medical Information requirements, scientific communication principles, pharmaceutical industry standards, and applicable regulatory and compliance factors.

• Proven capability to independently lead complex initiatives and functional responsibilities within a cross-functional, matrixed organization.

• Working knowledge of U.S. regulations regarding unsolicited requests, adverse event and product complaint reporting, and promotional reviews.

• Strong scientific acumen with the ability to critically assess clinical data, scientific literature, treatment guidelines, and other medical evidence.

• Exceptional written and verbal communication skills, with the ability to convey complex scientific concepts clearly and accurately to both scientific and non-scientific audiences.

• Strong project management, prioritization, problem-solving, and decision-making abilities.

• Capacity to manage multiple priorities in a fast-paced biotechnology setting.

• Ability to build productive relationships and influence cross-functional stakeholders without direct authority.

• Experience in hematology/oncology is strongly preferred.

• Experience in developing or delivering Medical Affairs scientific training and onboarding programs is preferred.

• Experience managing outsourced Medical Information contact centers and/or other external Medical Affairs vendors is preferred.

• Experience with product launches and significant clinical data releases is preferred.

• Experience with submissions related to compendia, clinical guidelines, and/or clinical pathways is preferred.

• Experience managing vendors and budgets is preferred.

• Travel requirements: less than 10% travel.

🏝️ Benefits

• Competitive base salary in the biotech industry.

• Annual target bonus, eligibility based on company performance.

• Stock options for new hires.

• Medical, Dental, and Vision benefits commencing on the first day of employment.

• 401(k) plan with company match.

• Paid time off and company holidays, including a company-wide shutdown at year-end.

• Paid Parental Leave.

• Life and Disability Insurance.

• Tax-advantaged health savings and spending accounts.

• A collaborative, hands-on culture.

• Mission-driven work focused on prioritizing patients.