Director, Medical Information

Cristcot

52d

About The Position

The Director, Medical Information will lead and manage planning and execution of Medical Information activities and materials for Cristcot’s portfolio. This critical role will lead creation of standard response documents to requests for medical information, establish and manage standardized ways of working with third party medical information service providers, and assist with medical review of materials developed by the company. Primary Relationships Within Cristcot, the Director, Medical Information will collaborate closely with Medical Affairs, Clinical Development, Pharmacovigilance, Regulatory Affairs and Legal. Outside Cristcot, the Director, Medical Information will build relationships with and agency partners, including a Medical Information Call Center.

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.
Ability to travel up to 30%.

Nice To Haves

Experience in gastroenterology and/or ulcerative colitis preferred.

Responsibilities

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 responses are evidence-based, accurate, and supported by the highest quality data.
Establish and maintain processes for managing unsolicited medical inquiries, adverse event reporting, and product complaint handling in accordance with company standard operating procedures and regulations.
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.
Familiar with technology solutions routinely used for review of standard response documents and medical materials via various CRM systems (e.g., Veeva PromoMats and/or MedComms).