Jobs · Information Technology

Associate Director / Director, Medical Information

Cognito Therapeutics, Inc. · United States · 1 mo ago
RemoteRemoteInformation TechnologyFull-time
We need to output HTML fragment with sections: About the role (maybe "About The Role" heading), Responsibilities, Qualifications, Benefits (since they mention benefits), maybe Pay/Schedule not present, so omit. Also include maybe "Other" not needed. Must not repeat job title. Must not include boilerplate like EEO, legal, accommodation, etc. Must preserve all substantive info. Must not include sections with filler. Must use

for headings. Use
  • for lists. Use

    for prose. We need to parse the posting. First paragraph: description of company. That's likely part of "About the role"? Actually "About The Role" heading appears later. The initial company description is likely part of "About the role" or could be separate "About the company". But instructions: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should have "About the role" heading and include the company description plus role description? The role description after "About The Role" includes details. So we can combine. Thus under

    About the role

    we put paragraphs describing company and role. Then Responsibilities: list bullet points from responsibilities section. Then Qualifications: list bullet points from qualifications (required and preferred). Might separate required vs preferred? Could combine but we can list all. Then Benefits: list bullet points from benefits. We must not include sections like Pay, Schedule if not present. We must not include "Other" etc. We must remove boilerplate: EEO, accommodation, legal, etc. Also remove "Physical Requirements & Work Environment" maybe not a standard heading; but it's substantive? It describes work environment. Could be considered part of "Other" but not a standard heading. The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. It doesn't say we cannot add other headings beyond the list; but they gave examples. Probably we should stick to those headings. Physical Requirements could be omitted as not in list; but it's substantive. However they said "use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests those are examples, not exhaustive. But they also say "Prefer a few substantive sections over many thin ones." Might be okay to add a section like "Work Environment". But safer to follow the given headings; we could incorporate physical requirements into About the role or Benefits? Probably better to add a "Work Environment" heading if we want to keep info. But they didn't list it; but they said "e.g." meaning examples, not limited. However they also said "Use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can use those headings; we could also add others if needed. I'd include a "Work Environment" section to preserve that info. But we must not include filler like "commensurate with experience" etc. In Qualifications they have "Associate Director/Director title level is commensurate with years of experience and required qualifications" - that's filler; we should avoid including that as a bullet if it's just filler. We should preserve substantive info but not include filler. So we can omit that sentence. Also "Competitive Benefits" heading is not needed; we just list benefits. We must not include "Physical Requirements & Work Environment" as heading if we decide to add Work Environment; we can keep the content. Let's extract content. Company description paragraph: "Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all." Then after "About The Role": "Cognito Therapeutics is seeking a driven, scientifically rigorous Associate Director/Director of Medical Information to build and lead the Medical Information (MI) function from the ground up. This is a hands-on role suited to a motivated individual contributor who wants to establish strong operational foundations and deliver high-quality scientific content in the Alzheimer’s and neurocognitive disease space. The role will design and implement core MI capabilities — inquiry management systems, standard response documents, and medical review workflows — positioning Cognito for its first commercial launch and for scaling as the pipeline grows. 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." We can combine these into About the role section. Now Responsibilities: there are subheadings: Build the Medical Information Function, Medical Review & Compliance, Scientific Content & Deliverables, Cross-Functional Partnership & Medical Affairs Strategy, Medical Affairs AI Initiatives. Under each there are bullet-like sentences. We need to produce a list (
    • ) of duties. We can combine all responsibilities into a single list, or we could keep subheadings but not required. Probably just a list. Let's extract each duty: From "Build the Medical Information Function": - 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 From "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 From "Scientific Content & Deliverables": - 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 From "Cross-Functional Partnership & Medical Affairs Strategy": - 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. From "Medical Affairs AI Initiatives": - 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 Now Qualifications: Required and Preferred. Required: - 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 (we can omit as filler) - 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 Preferred: - 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 We should not include the "Hybrid position preferred..." as a qualification? It's more about work arrangement; could be included under Preferred or maybe under Work Environment. We'll keep it under Preferred. Now Benefits: "Competitive Benefits Taking care of our own is one of our highest priorities. That’s why we offer benefits including unlimited PTO, wellness perks, virtual medical support, and health, dental, and vision insurance." We can list: unlimited PTO, wellness perks, virtual medical support, health insurance, dental insurance, vision insurance. Now Physical Requirements & Work Environment: "This role is primarily performed in an office or home-office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in-person meetings. Occasional travel to Cognito’s Cambridge, MA office or partner sites may be required." We can put under a heading "Work Environment". Or incorporate into About the role? Probably better separate. Now we must not include boilerplate: EEO, accommodation, legal, etc. So we omit those paragraphs. Now produce HTML. Structure:

      About the role

      company description + role description

      Responsibilities

      • ...
      • ...

      Qualifications

      • ...
      • ...

      Benefits

      • ...
      • ...

      Work Environment

      ...

      Make sure no extra whitespace? It's fine. Check for any filler like "commensurate with experience" - we omitted that line. Also "Associate Director/Director title level is commensurate with years of experience and required qualifications" we omitted. Check for any other filler like "competitive benefits" - we used benefits list. Check

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