Cognito Therapeutics
Associate Director / Director, Medical Information
Cambridge, Massachusetts, United States · Director
Sponsorship not specifiedDetected 1 day ago
Machine LearningData ScienceLLMsSalesforceVendor ManagementFDA RegulatoryPharmacovigilanceScientific WritingLeadershipCommunicationWritingRegulatory Affairs
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About the role
- The role will also contribute to Cognito's Medical Affairs AI initiatives, bringing scientific and operational judgment to the responsible deployment of AI-enabled tools for content generation and knowledge management.
Responsibilities
- Develop and maintain the MI quality framework, ensuring all scientific content meets regulatory, compliance, and scientific-integrity standards
- 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
Requirements
- Advanced scientific degree: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field
- Associate Director/Director title level is commensurate with years of experience and required qualifications
- 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
- Knowledge of Alzheimer's and other neurocognitive diseases
- Experience with KOL engagement, vendor management, and scientific content analytics
- 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 interpersonal skills, with the ability to build credibility and trust inside and outside the company
- Experience supporting pre-market approval/pre-BLA activities and commercial launch readiness for first-in-class therapies; device experience is a plus
- 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
Nice to have
- Experience supporting pre-market approval/pre-BLA activities and commercial launch readiness for first-in-class therapies
- device experience is a plus
- flexibility required during peak periods, which may include supporting critical operations outside normal business hours as needed
Benefits
- Build the Medical Information Function
- Medical Review & Compliance
- 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
- Cross-Functional Partnership & Medical Affairs Strategy
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This listing is sourced directly from Cognito Therapeutics's careers page and normalized into a canonical job model.