Manager/Associate Director, Medical Information
• Minimum of 7 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
• Experience with products with orphan drug status is highly preferred.
• Experience with inhalation products would be a plus
• Proficiency in medical writing, able to correctly understand, correctly interpret, and accurately communicate scientific data and statistical analyses
• Proven competency in utilizing literature search engines
• Strong understanding of the drug development process.
• Demonstrated understanding of legal, regulatory and compliance policies
• Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self－starter.
• Must have excellent communication and presentation skills （verbal and written / Japanese and English） with the ability to effectively present ideas and influence others that achieve desired results
• Demonstrated experience improving, developing and implementing new processes
• Flexible, diplomatic and able to effectively deal with ambiguity
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• An uncompromising ethical standard and level of conduct are essential.
• Proven ability to effectively work and thrive in a multi－cultural and cross－functional environment, while building strong relationships with all levels of people and teams as a team player
• Able to multi－task and prioritize projects
• Bachelor’s degree in life science
• Pharmacist license is a plus
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
• Travel up to 10－20％ （domestic and international）, some of which will be overnight in nature
This role will be primarily responsible for creating/updating/reviewing standard and custom response letters/ FAQs of response related to Company's products as well as communicating the information to internal and external stakeholders. In addition, this role will train front－line Medical Information Call Center in Japan on disease state, product information, and medical information processes.
Responsibilities will include, but are not limited to, the following:
• 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
• Ensures that responses to unsolicited medical inquiries and requests for medical information from healthcare professionals are in keeping with Company's Medical Information Standard Operating Procedures and in－line with Regulatory Authority regulations and local industrial standards.
• Conducts advanced literature searches for education and incorporation into medical information letters
• Summarize literature, clinical protocols, and clinical study reports
• Responds to escalated medical inquiries from healthcare professionals
• Collaborate continuously with Medical Information Call Center
• Helps ensure that all information pertaining to adverse events or product complaints received are forwarded to Company's Pharmacovigilance and/or Quality Assurance Department, respectively
• Support other activities in Global Medical Information, including Library Services and copyright
• Review commercial materials to ensure that the information is accurate, balanced and in line with both Global and local rules and regulations.