Senior Manager, Medical Affairs Technology and Digital Innovation

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Medical Affairs Technology and Digital Innovation.

Job Duties and Responsibilities

• Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as serve as the subject matter expert
• Serves as the Medical Information insights and reporting subject matter expert through the Medical Information call center vendor IRMS DV system
• This position will focus on Medical Information Systems for both the US and Myfembree Canada.
• Ensures our Medical Information platforms and content are reliable, compliant, and scalable to support current products as well as pipeline products.
• Supports and understands Medical Information and Medical Affairs systems and databases:
  • Perform overall management and administrative responsibilities of Veeva Vault Med Comms (content management system for medical review), IRMS, Microsoft office suite, team rooms, and other content management systems on daily bases (i.e. User Access Maintenance, Report generation, overall auditing) through technical expertise, managing new users, upgrading workflows for all review committees, identifying enhancements that can improve process efficiencies, and maintaining compliant solutions.
• Manages the MIRF process
• Create, implement and execute a newly enhanced SMPA Medical Affairs website after which manage and maintain (current) the SMPA website (www.SMPAmedicalaffairs.com) for content, access, and upgrades/ enhancements to ensure updates and all technical maintenance updates are managed.
  • Continuously seek improvements within systems to ease end user experience and make sure content is updated
• Manage Medical Review Committee MRC)
  • Make sure it adequately complies with the FDA requirements and SMPA policies regarding the dissemination of medical, scientific, and health economics and outcomes research (HEOR) information to healthcare professionals, both proactively and reactively.
  • Identify if the material is appropriate for MRC review and upload material to Veeva Vault MedComms for review.
  • Upload any offline discussions into Veeva Vault as a reference supporting material to ensure proper documentation of verdicts rendered by reviewers.
  • Communicate monthly MSRC/MedComms updates and metrics to Medical Affairs team.
  • Schedule and facilitate MRC face-to-face meetings when requested by reviewer or sponsors.
  • Continuously seek MRC process/workflow improvement
  • Manage the process and SOP
• Develops and execute project plans that ensure pre- and post-product launch preparedness for medical affairs content
• Implements innovations with respect to quality control mechanisms, supportive systems/databases, efficient inquiry handling workstreams, and overall dissemination of scientific information.
• Assists with the execution of publication plans and supports publication team needs including but not limited to publication workflows, reports and tracking of key congress dates and milestones (where applicable and needed)
• Executes ad-hoc project