Overview
Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company – one of Japan’s most respected – is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS).
MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.
The Manager, Business Operations and Transparency Reporting is responsible for (1) supporting transparency and reporting activities and (2) providing operational support to facilitate systems, workflows, and processes meeting transparency reporting and compliance requirements. This role will also lead key compliance-driven operational initiatives, projects, and activities for supporting the field operations. This person will liaise between internal functions and external service providers to ensure operational success of business operations and transparency initiatives.
Responsibilities
Transparency Reporting
- In coordination with third-party service provider, conduct activities such as collection, remediation, sub-certifying, and reporting, to support the integrity, accuracy and completeness of data submitted for Federal and State Transparency Reporting.
- Manage third-party vendor activities around preparation, validation, and submission of federal and state transparency reports to ensure complete and timely filings.
- Monitor and prepare data feeds of transparency related sources of spend data (e.g. HCP, Concur T&E, SAP etc.) from internal and external sources, communicate issues/findings to business units and vendors, and facilitate remediation.
- Provide operational expertise and change management experience (e.g., communication, training) for new system implementations and enhancements.
- Manage the process for handling physician disputes and assist with responding to and resolving physician disputes and inquiries from covered recipients.
- Create and revise policy, procedures, work instructions, and training guides for aggregate spend processes and related systems and workflows.
Business Operations
- Support and coordinate with third-party vendor health care provider (HCP) engagement process and patient/social activator/caregiver engagement process and systems.
- Support and facilitate grants and sponsorship workflows and systems
- Partner with various functional areas (e. g., Commercial Operations, Medical Affairs Operations, Medical Research, Marketing, Legal/Compliance, IT) to provide direction related to the development of compliant technology solutions; identify ways to leverage technology for improved reporting and trending.
- Provide guidance on process and operational support to ensure compliant field operations.
- Identify and participate in implementation of strategies, tools, and resources resulting in continual operational improvements leading to efficiencies and high performance
- Support operational projects with requirement gathering, status updates, communication cadence and project deliverables
- Maintain documentation and daily administration of multiple operational systems
- Identify best practices and industry trends and effectively implement for continual operational improvement
- Special projects
Qualifications
- Bachelor’s Degree
- Certification in healthcare compliance a plus
- 3 years direct, hands-on aggregate spend experience and practical experience
- 3-5 years life sciences operational experience
- Broad range of knowledge with hands-on experience with health care providers (HCP) and patient engagements, contracting and fair-market value (FMV), as well as grants, donations, sponsorships and exhibits, etc.
- Experience working with aggregate spend data reporting systems is required.
- Experience assisting with state marketing disclosures is a plus
- In-depth knowledge of how pharmaceutical and/or rare disease field operations function
- Must have knowledge of Sunshine Act/Open Payments requirements
- Must have knowledge of state marketing disclosure requirements
- Strong working knowledge and practical application of applicable laws, rules and regulations of the pharmaceutical industry
- Knowledge of system, data structure, data relationships, data integrity and auditing requirements
- Excellent analytical, planning, and process development skills.
- Strong organizational, problem solving and follow-up skills
- Proficiency in Concur systems is required.
- Hands-on knowledge and experience with operational systems, such as ComplianceWire, SAP, Transparency Reporting system,MDM, MedPro, Veeva, HCP Engagement Systems, and grant systems, while managing the system’s third-party vendors
- Advanced working knowledge of Excel, PowerPoint, business process development and Microsoft 365 apps.
- Ability to interpret, synthesize, and present qualitative/quantitative data derived from processes and operational systems.
- Exceptional attention to detail
- Proactive, flexible, responsive and resourceful
- Strong interpersonal skills used to collaborate, communicate, and influence across all levels of the organization
- Incumbent must be able to travel up to 10% of the time
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.
MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
The salary range for this position is $93,000 – $149,000. Factors such as scope and responsibilities of the position, candidate’s work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.
This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.