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Associate Director, Medical Information

Full TimeRemoteTeam 1-10Since 2017H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

22 hours ago

Salary

$185K - $220K / year

Postgraduate Degree7 yrs expEnglish

Job Description

• 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

Job 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

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