Medical Information Specialist

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 Medical Information Specialist will administer Santen’s medical education grants process, including optimizing policies and procedures, facilitating the grants committee, and administering responses and contracts. The Medical Information Specialist will also administer the medical materials approval process, including optimizing policies and procedures, administering the technology system, facilitating committees, and managing use and archival of medical materials. The Medical Information Specialist will assist with other administrative duties as required.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• 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
• Develop Medical Information product plans
• Provide periodic reports and metrics to GMA
• Manage Medical Information documents and contents (updates/archival/retirements)
• Provide scientific review of medical and promotional materials.
• Manage call center
• Participate in medical information globalization
• Support and participate in call center audits
• Support and participate in medical information process improvement and process implement
• 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
• 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.
• Serve as Medical, Regulatory and Legal process (MeRL) Coordinator
• Understand and continually improve upon Santen policies and procedures related the development, review, approval and use/archiving of medical materials
• Administer the technology portal used for medical materials development and use/archiving
• Drive medical materials through the life cycle of each document across four ophthalmologic therapeutic areas
• Schedule and facilitate MeRL Committee meetings, collect and distribute meeting minutes and action items
• Track life cycle of medical materials to ensure needed updates or expiries
• Assist with logistical planning for Santen sponsored medical education events, including scientific symposia and scientific open houses

QUALIFICATIONS:

• Advanced degree in life sciences
• Minimum of 3+ years previous relevant industry experience; at least 1 year of Med Info experience
• Familiar with many types of technology solutions, preferably as applied in the life sciences; including but not limited to: Vision Tracker, MedComms, DataVision, Tableau, and CRM
• Self-driven, independent and motivated; proactive; can-do attitude
• Strong organizational skills and ability to follow through with attention to detail
• Demonstrated history of securing cross-functional input and participation at various levels of a culturally diverse organization
• Exemplary interpersonal communication skills, both oral and written, and strong meeting facilitation skills
• Knowledge, understanding and adherence to global regulatory guidelines (e.g. FDA, EFIPA, PDMA, JPMA, PhRMA, etc.)
• Understanding of the regulatory and compliance environment related to Medical Affairs activities

For more information about our company and the work experience, please visit www.santenusa.com