More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! OBJECTIVES:
The purpose of this position is to lead Takeda's sample compliance program and ensure that it maintains alignment with FDA and PDMA regulations and guidance. This position will have the responsibility to work closely with the sales operations and associated outsourced vendors in the administration of the program. Functional scope includes the responsibility to support sample compliance policies, procedures, training and administration for:
- Signature Verification (Direct to Practitioner (DTP) and sales representative driven)
- Annual Inventory & Inspection
- FDA Reportable & FDA Assessment Readiness
- Significant Loss Thresholds(SLTs)
- Corrective Action
- Policies and Procedures
- Interim/Ad-Hoc business requests
- Monitoring and Data Analytics
This position is also responsible for adjusting the program as required to match changes in Takeda business practices as well as Takeda Legal and Compliance interpretation of FDA/PDMA regulatory guidance. ACCOUNTABILITIES: Leadership and Program Related:
Monitoring, Analytics and Remediation:
- Conduct a periodic review of all sample compliance processes, procedures, policies, and requirements for the purpose of confirming alignment with updates to regulations, pharmaceutical industry changes in practices and/or updated guidance by the FDA
- The individual in this role is expected to work independently and make solid judgments on interpretations of internal work processes and PDMA to determine whether specific field-based or internal department actions are in compliance with governing regulations
- Determine and execute monitoring and data analytics requirements to support the identification of potential compliance issues
- Lead the discovery, communication, remediation, and future prevention of sample compliance issues/violations
- Creates and periodically tests a response plan in the event of an FDA visit
- Assisting in the creation and maintenance of an effective system for appropriate follow-up and tracking of all sample FDA submissions and Takeda cases
- Leads and executes the full scope of sample compliance monitoring activities such as signature verification and annual inventory and inspection processes
- Continuously evaluates sample compliance tracking mechanisms, controls, documents, and systems for improvement opportunities. Implements changes where appropriate and in line with OEC directives.
- Supports monitoring of other commercial activities on an as needed basis
Third-party Vendor Management
- Identify potential issues and develop plans to resolve.
- Negotiate to create solutions in harmony with business needs.
- Create and lead working project groups.
- Manage the relationships with third-party vendors that support sample compliance activities. This includes vendor selection, project planning, proposals, timelines, contracts, budgets, and quality of work produced by internal and external resources.
- FDA Reportable and FDA Readiness Assessment
- Monitors, tracks and reports all sample thefts, falsifications, and loss activities in compliance with FDA requirements, tracks metrics and archiving for management reporting purposes
- Supports the sample investigations process as sample information or suspected activities warrant. Assists with actions, communication and assessment activities in a progressive fashion. Provides input and compliance perspective on corrective action and/or personnel decision outcomes
- Ensuring all FDA reportable incidents are appropriately reported/documented within the 5/30 day windows as required by the regulations
- Significant Loss Thresholds
- Monitors and helps define significant loss and lost in transit threshold methodology working with 3rd Party Vendors to revise as defined by Takeda policy
- Creates and administers a corrective action structure for sample compliance
- Assist the compliance investigation by gathering and reviewing investigation documentation and analyzing the information learned to determine whether a violation has occurred. Keep appropriate individuals informed as to the progress of the investigation and keeping all aspects of investigations confidential
- Policies and Procedures:
- Creates or revises policies and procedures as required to either support ongoing business activities or to reflect changes in OEC or Legal positions concerning sample compliance business activities
- Support other compliance teams on an as needed basis for either project-based or operational activities that pertain to the commercial function or other broader compliance initiatives
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Building networks with functions across Takeda and gaining support of cross-functional stakeholders to support sample compliance
- Research and respond to compliance hotline/helpline questions on an as-needed basis
- Partnering with other Takeda functions as required (e.g., Sales, Human Resources, Law Department, Security)
Education and Experience: Required:
- Bachelor's Degree and Masters (MBA) preferred
- Minimum of five years general business experience
- Experience managing business operations and/or workflow processes
- Regulatory Compliance and/or Supply Chain Planning/Inventory experience
Knowledge and Skills:
- Experience with Microsoft Office applications
- Strong analytical and technical experience desired
- Four years sample accountability, sales operations, auditing, sales reporting or analysis, compliance, training or related experience
- Experience training employees a plus
- Industry - understands pharmaceutical activities and prescription drug sales
- Regulatory - has understanding of applicable regulations that apply to the Sample, Sales & Marketing functional areas
- Operations - understands how to apply pharmaceutical regulations within a matrixed and highly visible environment
- Audit - can progressively analyze and trouble-shoot sample management activities for compliance with internal procedures and industry regulatory criteria
- Vendors - can effectively work with outsourcing business partners to meet Takeda business expectations
- Communication - effective negotiation and presentation skills both written and verbal
- Execution - ability to act on and implement initiatives in a time urgency manner
- Prioritization - can balance appropriate compliance risk with requisite business benefits
- Problem-solving - possesses strong analytical skills and can determine root cause and effect
- Relationships - ability to build and foster strong rapport in complex situations within a cross-functional culture
- Motivational - Provides effective influence to a cross-functional set of stakeholders. Can guide support function personnel
- Certified Compliance Professional is a plus
- Approximately 5% domestic travel is required.
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