Senior Manager, Medical Affairs Technology and Digital Innovation - Lifelancer

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 projects that require additional technical support
  
  

Key Core Competencies

• Excellent oral and written communication skills.
• Customer service skills.
• Organizational, time management, and planning skills.
• Highly self-motivated and able to handle multiple tasks in a timely fashion.
• Critical to this individual’s success will be his/her ability to interact with a wide range of functional areas within the organization, maintain a solution-oriented mentality, develop partnership and alignment among multiple internal stakeholders.
• Will be bold and innovative in thinking and yet pragmatic and efficient in approach.
  
  

Education And Experience

• Bachelor’s degree in a related field required.
• 2-3+ years Medical Information or Medical Affairs or equivalent pharmaceutical industry experience is preferred.
• Familiarity with PC based applications, including Microsoft Word, Excel and PowerPoint.
• Technical expertise with content management systems (Veeva Vault) and customer relationship management systems (IRMS, Salesforce)
• The role requires experience with commercial organizations, legal, medical and regulatory needs as well as internal pharmaceutical and biotechnology business processes and program/project management familiarity.
• The individual will also be responsible for project coordination to improve processes and should be versed on operational efficiencies.
• This candidate will have knowledge regarding AI technologies in a patient centric environment.
• The role requires experience working independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive solutions forward. The ideal candidate can lead a project effectively.
  
  

The base salary range for this role is $142,800 to $178,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW

EEO is the Law Poster Supplement

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