Director – Medical Information

Director – Medical Information

Requirements

• An advanced degree is required (e.g. PharmD, MD, PhD)
• Minimum of 10 years working in a Medical Information capacity at a pharmaceutical or biotech company, ideally in the area of Pulmonology and/or Infectious Diseases and/or orphan/rare diseases
• Thorough understanding of regulations, compliance and industry standards relating to communicating product information to HCPs and/or consumers
• A great teammate, assertive communicator, and willingness to continuously learn the disease state, product, etc.
• Proficiency in medical writing, able to correctly understand, correctly interpret, and accurately communicate scientific data and statistical analyses
• Excellent communication (written, verbal, presentation) and analytical skills in a dynamic environment
• Demonstrated proficiency in applying literature search engines
• Demonstrates a strong command of the English language (oral and written)
• Proven ability to effectively work and thrive in a multi-cultural and cross-functional, global environment, while building strong relationships with all levels of people and teams
• Shown ability to work within a multi-functional team (legal, regulatory, clinical/medical, quality, research, etc.)
• Able to multi-task and prioritize projects
• Located within reasonable driving distance of Insmed headquarters in Bridgewater, NJ
• 10-20% Travel

Responsibilities

• Creates, updates, and reviews standard and customized response letters and FAQs containing information available from reliable sources, including published medical literature, recently conducted clinical trials and data analyses, changes in product labeling, and from recent changes in regulations
• Medical reviewer for the medical and commercial review committees
• Ensures that responses to unsolicited medical inquiries and requests for medical information from healthcare professionals and patients are timely, accurate, unbiased, and in keeping with Insmed’s Medical Information Standard Operating Procedures and in-line with Regulatory Authority regulations
• Conducts advanced literature searches for education, internal company use, and incorporation into medical information letters
• Summarize literature, clinical protocols, and clinical study reports
• Responds to advanced medical inquiries from healthcare professionals
• Continuously collaborate with and train the front-line Medical Information Call Center on disease state, product information, and medical information processes
• Help staff the medical information booths at conferences to provide unsolicited medical information to healthcare providers
• Helps ensure that all information pertaining to adverse events or product complaints received by MI staff are forwarded to Insmed’s Pharmacovigilance and/or Quality Assurance Department, respectively
• Collaborate with global colleagues in EMEA and Japan
• Participate in Global Medical Information and cross-functional projects as needed

Preferred Qualifications

No preferred qualifications provided.