Works with internal stakeholders such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE, Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain for successful end-to-end tracking and implementation of Company Core Data Sheets (CCDSs) into local labeling.
- Brings deep understanding of Takeda processes and labeling requirements as a close partner on Global Labeling leadership team
- Responsible for maintaining QMS documentation for Global Labeling in compliance with QA requirements. Also supports determination of associated training requirements.
- Provides guidance regarding Quality Management System (QMS) documentation standards and compliance requirements with regard to global labeling.
- Serves as the primary point of contact for Global Labeling and Quality Assurance for audit preparation, audit support, Quality Event Management, and CAPA creation, tracking and resolution.
- Provides periodic reporting of compliance status, metrics, and risk mitigation measures to Sr. Management.
- Manages escalation processes within Global Regulatory Compliance and Global Labeling to ensure proactive compliance with implementation timelines.
- Works with Information Technology and Global Labeling to plan, implement and maintain adequate Labeling databases and tracking systems that are supportive of labeling processes and integrated with the overall Takeda information technology platform.
- Drafts new and updated labeling commitments for Partner Agreements relevant to CCDS and local label changes. Maintains system to tracks compliance to commitments.
Implementation and Maintenance of the End-to-End (E2E) Tracking Process for labeling:
- Represents the business and compliance needs while facilitating the development and maintenance of the E2E Tracking system.
- Builds partnerships with internal stakeholders to ensure adherence to processes, adoption of technology, and streamlined interfaces with shared systems.
- Works with IT and Regulatory Operations to ensure tracking system meets the needs of internal stakeholders and Health Authorities expectations
- Works with Global Labeling, IT and Regulatory Operations and other stakeholders to assess and provide clear requirements assuring systems best facilitate business process and support the evolving company structure and portfolio.
- Manages the escalation and risk mitigation process.
- Continuously assesses compliance gaps and provides recommendations for risk mitigation to Sr. Management.
- Reviews and approves periodic compliance metrics reporting to Sr. Management and for related internal and external reporting, e.g., Pharmacovigilance System Master File
- Proactively escalates urgent issues to Global Labeling and Global Regulatory Compliance LT for awareness and resolution
- Oversees vendor support for ongoing compliance monitoring, data gathering, and metrics report generation.
Supports internal and external audits:
- Participates on inspection readiness teams
- Coordinates or directly provisions Global Labeling documentation requests prior to, during, and in follow-up to inspections
- Serves as the point of contact with QA to provide CAPAs with Global Labeling consultation
- Ensures all CAPAs are tracked until closure.
- Partners with QA to ensure that internal audits are assessing E2E Labeling compliance
Ensures Labeling Commitments to partners and third parties are documented and tracked in the appropriate repository:
- Ensure maintenance of Labeling Agreements and labeling commitments in associated agreements owned by other functions, e.g., Pharmacovigilance Agreements
- Work with due diligence and other program teams to ensure that Labeling Agreements are put in place, as needed.
- Identify and implement information management system to track agreements and compliance status.
Implements and maintains quality documentation for Global Labeling:
- Maintains Global Labeling QMS documents and ensures adequate and appropriate documentation of Labeling processes in compliance with QA requirements and standards
- Ensures appropriate training is assigned and completed for Global Labeling staff and assures awareness of Labeling training for external stakeholders
- Provides diligence and support to assure vendor processes are supportive of Takeda processes and labeling requirements
Education and Experience Requirements
- Bachelor's degree in a scientific discipline or closely related field is required
- Minimum of 8+ years of regulatory experience in the pharmaceutical/biotechnology industry
- Understanding of pharmaceutical drug development and global regulations pertaining to labeling
- Experience as project manager is highly preferred.
- Understanding of Electronic Document Management Systems, Regulatory Information Management, and Labeling Tracking systems to a sufficient level to support labeling documentation and tracking
- Knowledge of Quality Management Systems (e.g. TrackWise), electronic document management systems, and compliance requirements
Key Skills, Abilities, and Competencies
- Global experience is strongly desired.
- Excellent analytical, technical and problem-solving skills.
- Comfortable with technology and understands information technology to a level that helps with IT collaboration (assure systems best facilitate business process)
- Strong attention to detail and accuracy is a must.
- Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
- Ability to present information effectively to senior management and influence timely and robust decision making.
- A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
- Ability to manage complex projects, integrate planning efforts and timelines across departments in a matrix team environment.
- Ability to articulate a clear vision and help others understand their relationship between their roles, the roles of others and the overall goals of Takeda.
- Maintains knowledge of current regulation, guidance and enforcement and communicates changes within regulatory and to cross-functional teams.
Complexity and Problem Solving
- Consistently works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors across different functional areas of the business.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Requires good knowledge of the functional area, business strategies, and the company's goals.
Other Job Requirements
- Domestic and international travel may be required for this position.
- Approximately 10% travel is required.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.