Sr. Medical Information Manager

COMPANY DESCRIPTION

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Senior Medical Information Manager is responsible for development and delivery/implement of strategic and tactical planning and related medical information content and scientific deliverables. The Senior Medical Information Manager will be responsible for ensuring medical and scientific accuracy of all content, responding to escalated inquiries and reporting on product/therapeutic area medical information metrics, trends and analytics to help inform product development planning and strategy. The Senior Medical Information Manager role will also support and actively participate in the globalization of medical information across North America, EMEA and APAC regions.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Develop strategic and tactical plans for products in the aligned therapeutic area
• Manage medical writing vendors to develop and deliver Medical Information (MI) content (Standard Response Letters [SRLs], FAQs, Compendia) for the aligned products and therapeutic areas
• Provide authoring support for SRLs as needed
• Provide guidance on compliance in MI
• Manage Medical Information documents and contents (updates/archival/retirements)
• Provide scientific review of medical and promotional materials.
• Manage Tier 2 escalated inquiries and one-off responses
• Provide subject matter expertise (SME) and accuracy checks for medical materials review, support creation and review of both standard and custom responses
• Support training of call center staff in all global regions through both live assistance and creation of user manuals and other training materials
• Manage communications (internal and external) regarding product medical information deliverables. Liaise as needed with internal stakeholders to update and maintain SRLs and medical information material.
• Manage external medical communication agencies to develop timelines and manage the process for successful execution of assigned projects
• Work with regional Medical Affairs colleagues on a global basis to ensure consistency and efficiency of medical information responses worldwide
• Staff the Medical Information Booth at congresses
• Determine and deliver appropriate MI Reports Insights and Analytics to help inform product medical priorities, strategies, and tactics
• Support and actively participate in activities related to globalization of Medical Information as needed
• Ensure medical and scientific accuracy of all content deliverables
• Ensure incorporation of customer and/or patient insight into core scientific materials where appropriate.

QUALIFICATIONS:

• Advanced degree in Scientific Discipline or applicable Health Sciences field (e.g., PharmD, PhD; MD)
• Minimum of 5 years previous Global or US Medical Information experience.
• Demonstrated comprehensive experience in Medical Information and applicable regulations
• Strong ability to effectively collaborate with various roles within the global organization
• Excellent oral and written communication skills and interpersonal skills
• Demonstration of strategic thinking
• Understanding of the medical information needs for various customer segments and geographic regions
• Ability to identify the most efficient and effective way to implement new services
• Ability to translate scientific data to various audiences
• Knowledge of IT needs for global project development and implementation
• Strong presentation, facilitation, and instructional skills
• Travel approximately 15-20% annually