Sr. Medical Information Manager

  • Full-time

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health, and addressing vision-related social issues for people around the world. Santen USA, headquartered in Emeryville, Calif., is an important part of our worldwide efforts and is home to our regional business teams. We have about 350 total employees in North America, including our other offices located in Toronto, Canada, Fort Worth, TX and Miami, FL. For more, visit https://www.santenusa.com/.

Job Description

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.

  • Develop strategic and tactical plans for products in the aligned therapeutic area
  • Manage medical writing vendors
  • Author, review, QC of standard response letters/documents (SRLs/SRDs), FAQs, other MI assets as needed. Manage Medical Information documents and contents (updates/archival/retirements)
  • Support call center. Handle escalated inquiries and one-off /custom responses. Participate/support QA audits. Perform case log audits
  • Provide scientific review of medical and promotional materials
  • 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
  • Experience with operating and/or managing IRMS or medical information query management systems is highly desirable.
  • Experience with Veeva desirable.
  • 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

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19. Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit https://www.santenusa.com/career-culture

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