Associate Director, Medical Information
CultureHQ
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $185,000 - $220,000 per year
Job Level
About the role
- Lead the Medical Information strategy aligned with Cogent Biosciences’ clinical development and commercialization plans
- Assist with establishing Medical Information governance, best practices, and operational standards across the organization
- Lead Medical Information launch readiness activities; primary focus on acting as Medical Lead for Medical‑Legal‑Regulatory Review Committees
- Additional activities include development, review and approval of FAQs, SRLs, and reactive content to support pre‑ and post‑launch needs
- Act as a primary Medical Affairs representative on PRC/MRC review committees, with accountability for scientific accuracy and balance, of materials
- Drive alignment between Medical Information, Medical Affairs, Patient Advocacy, Regulatory, Legal, Clinical, and Commercial teams to ensure consistent messaging at launch
- Partner closely with Medical Affairs leadership, Clinical Development, Regulatory Affairs, Commercial, Patient Advocacy, and Market Access to support enterprise‑wide objectives
- Serve as a scientific subject matter expert for products and pipeline assets to execute on deliverables
- Develop medical information content, data on file and call center materials as required
- Assist with the intake and fulfillment of unsolicited requests as needed
- Generate reports and lead the analysis of medical inquiry trends and insights to inform Medical Affairs strategy, evidence generation, and stakeholder education
- Assist with monitoring key performance indicators (KPIs) to ensure quality, timeliness, and impact of Medical Information deliverables as needed
- Use insights to drive continuous improvement of content, processes, and customer engagement
- Assist with the oversight of Medical Information operations, including inquiry management processes, systems, and external vendors or call centers as applicable
- Ensure alignment with SOPs, quality standards, and inspection readiness requirements
- Comply with all applicable guidelines, policies, and legal, regulatory, and compliance requirements
- Assist Medical Information Leadership with key projects, as needed
Requirements
- Advanced scientific or clinical degree (PharmD, PhD, MD, or equivalent)
- Minimum 7–10 years of pharmaceutical or biotechnology industry experience within Medical Information, Medical Affairs, or related scientific functions
- Deep understanding of Medical Information regulations, compliance requirements, and MLR review processes, particularly in a launch setting
- Experience in hematology, oncology, and/or rare diseases preferred
- Experience working in clinical stage companies transitioning to commercial stage and build-out of Medical Information function preferred
- Previous new product launch experience
- Demonstrated ability to lead cross‑functional teams and work collaboratively in a matrix organization
- Strong strategic thinking, decision‑making, and problem‑solving capabilities
- Excellent written and verbal communication skills, with the ability to translate complex data into clear, compliant scientific messages
- Knowledge of FDA regulations regarding the dissemination of Medical Information, and adverse event and product quality complaint reporting
- Ability to travel to scientific congresses and internal meetings as needed (~15%)
Benefits
- Health insurance
- 401(k) match with immediate vesting
- Generous paid time off
- 12 weeks of fully paid parental leave
- Paid family and medical leave for all employees
- Company-paid short-term disability coverage for up to 20 weeks
- Wellness programs
- Tuition reimbursement
- Inclusive family-forming support
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical Information strategyMedical Information governanceMedical-Legal-Regulatory Reviewdevelopment of FAQsdata analysisKPI monitoringinquiry management processescompliance requirementsFDA regulationsadverse event reporting
Soft Skills
leadershipstrategic thinkingdecision-makingproblem-solvingcollaborationcommunicationscientific accuracycustomer engagementcontinuous improvementmatrix organization
Certifications
PharmDPhDMD