Associate Director, Medical Information

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

📋 Description

• Create, assess, and uphold Standard Response Documents, FAQs, and tailored scientific responses.

• Collaborate on content planning and prioritization for inquiry requirements, emerging data, publications, regulatory milestones, and readiness for launch.

• Organize Medical, Legal, and Regulatory submissions, address stakeholder feedback, and facilitate timely approvals and updates to content.

• Address inquiries from healthcare professionals and patients/caregivers, including complex or escalated requests.

• Review literature and consult with subject matter experts.

• Assist with intake, triage, documentation, and escalation processes.

• Oversee response quality and timeliness.

• Report adverse events and product complaints to Pharmacovigilance and Product Quality.

• Support medical congress initiatives and collaborate with Field Medical on inquiry intake, transfer, and escalation.

• Manage daily operations of Medical Information and outsourced contact center services.

• Supervise service levels, deliverables, response quality, training, and issue resolution.

• Partner with the Senior Director on vendor performance, scope, capacity, budget contributions, resource recommendations, corrective actions, and continuous improvements.

• Coordinate scientific and operational training for vendors and internal stakeholders.

• Assist in preparing for emerging data, program milestones, and potential launches.

• Develop, implement, and maintain Medical Information SOPs, work instructions, quality standards, and training documentation.

• Keep inspection-ready records and assist with audits, inspections, and remediation activities.

• Identify operational and compliance risks and suggest enhancements.

• Provide scientific and operational support to colleagues and vendor staff.

• Manage Medical Information metrics and insights.

• Analyze inquiry trends, content gaps, emerging scientific requirements, and operational performance.

• Consolidate Medical Information findings into reports and presentations for leadership and cross-functional stakeholders.

• Report to the Senior Director, Medical Information & Operations.

• Collaborate across functions to facilitate compliant scientific exchange.

⛳️ Requirements

• Advanced degree (PharmD, PhD, or equivalent scientific background preferred).

• 6-8+ years of experience in biotech/pharma, including a minimum of 3 years in Medical Information or closely related scientific communications roles.

• Proven experience in developing scientific response content, evaluating literature, addressing medical inquiries, and supporting MLR review.

• Strong understanding of laws and regulations relevant to Medical Information, including non-promotional scientific exchange, safety reporting, and data privacy.

• Excellent scientific writing, communication, analytical, and organizational abilities.

• Capacity to collaborate across functions, make sound judgments, and manage competing priorities.

• Familiarity with inquiry management, content management, or MLR platforms, such as Veeva PromoMats, SharePoint, or similar systems.

• Comfortable working in a fast-paced, dynamic environment.

• Approximately 10% travel required.

• Preferred: experience in rare disease and/or neurology.

• Preferred: experience in global MI operations, including audit and/or inspection support.

• Preferred: experience in managing outsourced MI operations, vendor performance, training, and quality improvement.

• Preferred: experience in developing MI SOPs, content governance, and operational workflows.

• Preferred: experience in scaling MI capabilities to support readiness for launch and transitioning from clinical development to commercialization.

• Preferred: experience in translating MI trends into actionable recommendations and presenting insights to senior stakeholders.

🏝️ Benefits

• Annual bonus.

• Equity participation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Long-term disability insurance.

• Short-term disability insurance.

• Paid parental leave.

• 401K plan with company match.

• Unlimited vacation time.

• Tuition assistance.

• Employee Stock Purchase Program (ESPP).

• Flexible work arrangements.