As the Medical Information Manager / Senior Manager, you will be responsible for providing accurate, timely, fair-balanced medical information in response to medical inquiries from internal customers (MSLs, sales, national account managers) and external customers (healthcare professionals and consumers). You will ensure compliance with all relevant SOPs, FDA, and OIG regs/guidances, adverse event and product complaint handling and become an expert in our products and corresponding food allergy/immunology therapeutic area.
You will create response documents after conducting a literature search, using PubMed and Embase, and choose appropriate information for inclusion and may assist in medical, legal, and regulatory review of submissions. Providing after-hours support for emergency medical inquiries escalated from the call center vendor will be key.
Write, review, and maintain/update/retire standard and custom response letters, global core response documents and FAQs
Perform literature searches; and in-depth research, analysis and interpretation of medical data
Assist in the creation of metrics and performance reports to Senior Management
Perform routine QA/QC of med info vendor
Develop/deliver med info training for sales, national account managers, MSLs, med info vendor and assist with staffing booth at national conventions/meetings
PharmD – Must be a licensed pharmacist
5+ years of providing medical information in the pharma/biotech industry
Medical, legal, and regulatory review experience
Excellent verbal, written communication and customer service skills
Proven ability to perform in-depth research, analysis and interpretation of medical data and assemble evaluated information into an accurate, comprehensive and concise response document
Must have working knowledge of the applicable FDA regulations/guidances, including OIG
Overnight travel (up to 15%), possibly including weekends
Internal Number: 1
About DBV Technologies
Dedicated to Improving the Lives of Patients with Food Allergies and Other Immunological DiseasesDBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians and entrepreneurs who believed that food allergies could one day be treated safely and effectively. With this mission driving our commitment to the advancement of treatments in this field, we are investigating a potential new class of immunotherapy that aims to activate the immune system of patients through the skin.For more than 15 years, we have been on a journey to advance skin immunotherapy, which merges deep science with patented manufacturing technologies and proprietary manufacturing to develop treatment options for diseases with significant unmet medical need.Today, we are focused on exploring the use of skin immunotherapy to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey of developing medicines, we hope to potentially offer the first FDA approved epicutaneous immunotherapy (EPIT™) treatment for peanut allergy.