Cristcot
Pharmaceuticals • Biotechnology
Cristcot is a strategic pharmaceutical company focused on gastroenterology, developing a novel hydrocortisone acetate (HCA) suppository formulation and delivery device intended as a rapid-acting rescue therapy for ulcerative colitis (UC). Its lead product has completed Phase 3 clinical trials with an endpoint of mucosal healing and clinical remission in four weeks, and is designed for use alone or alongside maintenance therapies. Cristcot holds composition, utility, device and manufacturing patents and aims to address an unmet need in UC treatment by improving drug placement, reducing leakage, increasing retention and accelerating bioavailability.
Director, Medical Information
Job not on LinkedIn
November 21
Cristcot
Pharmaceuticals • Biotechnology
Cristcot is a strategic pharmaceutical company focused on gastroenterology, developing a novel hydrocortisone acetate (HCA) suppository formulation and delivery device intended as a rapid-acting rescue therapy for ulcerative colitis (UC). Its lead product has completed Phase 3 clinical trials with an endpoint of mucosal healing and clinical remission in four weeks, and is designed for use alone or alongside maintenance therapies. Cristcot holds composition, utility, device and manufacturing patents and aims to address an unmet need in UC treatment by improving drug placement, reducing leakage, increasing retention and accelerating bioavailability.
📋 Description
• Lead and manage planning and execution of Medical Information activities and materials for Cristcot’s portfolio. • Lead development of relevant materials and activities to respond to unsolicited queries received about Cristcot or Cristcot products. • Develop and manage the Medical Information strategic and tactical components of the cross-functional annual Medical Affairs plan. • Lead creation of standard response documents to address unsolicited requests for information on Cristcot or portfolio products. • Ensure that all materials are current, scientifically accurate, and compliant with applicable regulations (e.g., FDA, EMA, etc). • Monitor and analyze inquiry trends to identify knowledge gaps and provide insights to internal stakeholders for strategic planning. • Represent Medical Information at internal and external meetings (conferences and congresses). • Assist with review of scientific and promotional content in accordance with company policies, ensuring all material is accurate and supported by references. • Oversee the development of relevant Medical Information training materials for relevant employees. • Collaborate with cross-functional colleagues in Medical Affairs, Regulatory, Legal, Quality, Pharmacovigilance, and Commercial to provide support for products throughout lifecycle.
🎯 Requirements
• Advanced/doctoral degree in health sciences (PharmD, MD, PhD) required. • 6+ years of experience in Medical Affairs and Medical Information. • Prior experience in the development of Medical Information response documents. • Understanding of the legal and regulatory environment within the pharmaceutical industry, and past experience reviewing scientific and promotional materials for scientific/clinical accuracy. • Experience with project and vendor management, including overseeing content development by medical communications agencies and management of a third-party call center. • Experience in gastroenterology and/or ulcerative colitis preferred. • Ability to travel up to 30%.
🏖️ Benefits
• Health insurance • Remote work options
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