Overview

The Senior Manager, Medical Information provides in-depth scientific knowledge expertise to handle medical information requests from healthcare professionals and customers. The role can serve as a therapeutic area and product expert for both internal and external customers. This role must also demonstrate an advanced level of knowledge of drug information databases and systems, and Medical Information processes and procedures. The Sr. Manager, Medical Information will contribute to the planning, development, and maintenance of scientific medical information content and projects, and will be responsible for timely dissemination of current, accurate, and balanced product information. This role will also provide support and medical services in cross-functional product teams and will provide guidance on escalated Medical Information Requests to junior level team members and Call Center Staff.

Responsibilities

The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.

• Develops and updates scientific content, including Scientific Response Documents (SRDs), FAQs, and AMCP Dossier in preparation of launch and throughout product life cycle. Contributes to strategic planning of Medical Information content and resources.
• Ensures timely, accurate, balanced, and up-to-date scientific responses to medical inquiries from health care professionals.
• Provides thorough review and approval of high-quality and clinically accurate Medical Information resources (SRDs, FAQs) and custom response documents.
• Provides oversight to Medical Information Associates or Call Center Staff creation of responses to complex customer inquiries.
• 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 and scientific content.
• Staffs Medical Information Booths at live Scientific/Medical Meetings. Will contribute to Medical Booth planning as needed.
• Provide Medical Information training to Shionogi Inc. sales representatives, outsourced vendors, and new hires.
• Actively participates in vendor selection and management, including Call Center, AMCP dossier, and medical writing agencies.
• 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 five (5) years of Medical Information experience in 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.
• Familiarity with therapeutic areas related to the company's products.
• 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.

Competencies

• 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 meet established deadlines.
• Excellent project management and time management skills
• Analytical, solutions-oriented, negotiation and strategic-thinking skills
• Highly self-motivated and able to handle multiple-tasks in a timely fashion
• Experience in medical w