The Manager, Medical Information has in-depth scientific knowledge of Shionogi medicines and therapeutic areas to respond to medical information requests from healthcare professionals and customers through various communication channels. The Manager, Medical oversees the planning, development, and maintenance of scientific medical information content, and will be responsible for timely dissemination of current, accurate, and balanced medical information. The Manager will be expected to independently provide medical support and expertise in cross-functional product teams, including medical and promotional review teams. This role must also demonstrate an advanced level of knowledge of drug information databases and systems and Medical Information processes and procedures.

Responsibilities

• Ensures timely, accurate, balanced, and up-to-date scientific responses to medical inquiries from health care professionals and customers via various communication channels. Responsible for phone coverage as needed.
• Lead the development, update, and reviews of Medical Information (MI) scientific content, including Scientific Response Documents (SRDs) and FAQs. Support development and update of approved product AMCP Dossier.
• Ensures complex scientific content is summarized in concise and balanced manner by thoroughly reviewing and approving high-quality SRDs, FAQs, and custom response documents.
• Analyzes and communicates medical and scientific insights and customer inquiry trends via development of reports and presentation to key internal stakeholders.
• Participates in Promotional Review and Medical Review Committees to ensure medical accuracy of promotional materials, sales training material, corporate communications, and scientific content.
• Staffs Medical Information Booths at live Scientific/Medical Meetings and contributes to Medical Booth planning as needed.
• Provide Medical Information, product, and disease state training to Shionogi Inc. sales representatives, Medical Information Call Center and other vendors, and new hires.
• Recognize, capture, and report adverse events and product quality complaints.
• Adhere to all applicable Shionogi SOPs, policies, processes, and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information, and report AEs and PQCs.

Minimum Job Requirements

Qualifications

• Advanced scientific degree (such as PharmD, PhD, MD, RN or equivalent) is preferred.
• Minimum of three (3) years in Medical Information or five (5) years in the pharmaceutical or healthcare-related industry.
• Significant experience in scientific content development, medical information, or a related field.
• Strong scientific background with a deep understanding of medical and clinical concepts.
• In-depth knowledge of legal and regulatory requirements related to the pharmaceutical industry, and dissemination of medical information, drug promotion, and adverse event and product quality complaint reporting.
• Ability to ensure compliance with Standard Operating Procedures (SOPs), policies, and guidelines.
• Experience in providing training to sales representatives, outsourced vendors, and new hires on medical information and related topics.
• Capable of recognizing, capturing, and reporting adverse events and product quality complaints in compliance with regulatory standards.
• Adherence to ethical standards in responding to medical inquiries, disseminating scientific information, and reporting adverse events and product quality complaints.

• Excellent technical writing and verbal communication skills, organizational skills, and attention to detail.
• Demonstrated computer experience with MS Word, Excel, Access, and Outlook.
• Ability to effectively prioritize, multi-task, and work independently to meet established deadlines.
• Excellent project management and time management skills
• Analytical, solutions-oriented, negotiation and strategic-thinking skills
• Highly self-motivated and able to work independently in order to manage multiple tasks in a timely fashion
• Proven track record in working in a dynamic, cross-functional environment

• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required 50% per month, at least 2-3 days per week.

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.