Associate Director / Director, Medical Information

United States·Cambridgeexecutive

OtherAssociate

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Quick Summary

Key Responsibilities

operating model, technology infrastructure, and SOPs Develop and maintain the MI quality framework, ensuring all scientific content meets regulatory, compliance,

Requirements Summary

PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field Minimum 6 years of Medical Information experience in the device, pharmaceutical, or biotechnology industry.

Technical Tools

OtherAssociate

About the Role

~1 min read

Establish the MI department from the ground up: operating model, technology infrastructure, and SOPs
Develop and maintain the MI quality framework, ensuring all scientific content meets regulatory, compliance, and scientific-integrity standards
Serve as the internal subject matter expert on MI best practices, regulatory expectations (FDA, EMA/MDR/Notified Bodies), and industry benchmarks for neurocognitive disease and advanced therapies

Build and oversee the medical review process for promotional and non-promotional materials, ensuring scientific accuracy and alignment with labeling/IFU and clinical data
Partner in establishing a Medical Review Committee (MRC) / Promotional Review Committee (PRC), working closely with Regulatory Affairs, Legal, and Commercial

Create and maintain a comprehensive library of standard response documents (SRDs), custom responses, and medical FAQs covering Cognito’s neuromodulation device pipeline across neurocognitive disease indications
Author and review medical information letters, and contribute to disease education materials, clinical summaries, and scientific dossiers for internal and external use
Ensure all MI content reflects the current evidence base — clinical trial data, real-world evidence, and peer-reviewed literature

Partner with Scientific Communications, Clinical Development, and Commercial to develop scientifically rigorous training materials, slide decks, and internal reference tools
Lead development of pipeline and disease-area resources enabling cross-functional teams to communicate accurately about Alzheimer’s and the broader pipeline
Contribute to publication planning and medical education initiatives supporting pre- and post-launch Medical Affairs strategy
Collaborate with Patient Advocacy and Scientific Communications to ensure content is accessible, accurate, and patient-centered
Partner closely with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other functions to support compliant scientific exchange and launch readiness.

Contribute as the Medical Affairs subject matter expert to Cognito’s AI strategy, partnering with Data Science, IT, and Medical Affairs leadership to evaluate and implement AI-enabled solutions
Support design and validation of AI-assisted MI tools, including intelligent response generation, literature-surveillance automation, and content quality-checking workflows
Help establish governance frameworks for responsible AI use in medical communications — bias assessment, hallucination mitigation, and compliance review protocols
Monitor the evolving regulatory and industry landscape around AI in medical affairs (FDA guidance, ISPE, PhRMA frameworks) and translate insights into actionable policy

Requirements

~1 min read

Advanced scientific degree: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field
Minimum 6 years of Medical Information experience in the device, pharmaceutical, or biotechnology industry. Associate Director/Director title level is commensurate with years of experience and required qualifications
Deep understanding of Medical Information regulations and compliance requirements
Experience contributing to or building MI capabilities, including SOP development and content library management
Solid working knowledge of medical review processes (MRC/PRC) and promotional/non-promotional content review, with familiarity with applicable FDA and EMA/MDR regulations
Strong scientific writing skills, with experience developing SRDs, MI responses, and clinical content for internal and external audiences
Excellent written and verbal communication skills, with the ability to translate complex scientific and clinical data into clear, compliant messaging
Ability to work effectively cross-functionally in a fast-paced, pre-commercial biotech environment with lean teams and evolving priorities
Excellent interpersonal skills, with the ability to build credibility and trust inside and outside the company

Nice to Have

~1 min read

Knowledge of Alzheimer’s and other neurocognitive diseases
Experience supporting pre-market approval/pre-BLA activities and commercial launch readiness for first-in-class therapies; device experience is a plus
Experience with KOL engagement, vendor management, and scientific content analytics
Familiarity with MI platforms (e.g., Veeva Vault, Salesforce Health Cloud, MedAnswers) or emerging AI-powered MI solutions
Exposure to AI/ML applications in Medical Affairs or Medical Information, including prompt engineering, LLM evaluation, or AI governance

Hybrid position preferred; flexibility required during peak periods, which may include supporting critical operations outside normal business hours as needed