The purpose of this position is to provide leadership and overall direction for global import/export staff within CMCC. This position is responsible for providing the strategic direction and development of processes relating to the international movement of materials in support of Takeda s development programs. The individual in this position is responsible for ensuring that international movement of materials to support R&D programs is compliant with all applicable laws and regulations in the relevant countries. This position interacts with and influences all functional areas with Takeda involved in the import/export of research materials.
- Develops and manages the CMCC global importation and exportation strategy by working closely with staff in PDD, PRD and other Takeda groups to ensure all material used in clinical trials and research and development activities is moved in accordance with the rules and regulatory requirements of Customs, FDA, USDA and other applicable governmental agencies world-wide.
- Responsible for managing all matters of foreign trade relating to the import and export of all Clinical Trial Material (CTM), ensuring all product movements meet the compliance expectations of each country in concert with the timeline needs of Takeda s clinical trials.
- Is primary respondent to all regulatory agency inquiries and issues. Investigates and develops strategy and response to ensure compliance in accordance with appropriate laws and regulations.
- Develops, analyzes and implements process and procedures for tracking/tracing and ensuring documentation compliance of material shipments for Takeda and vendors. Investigates and manages resolution of potential issues to ensure Takeda remains in compliance with appropriate regulations and laws
- Oversees the compliance activities for CRO and packaging vendors conducting import/export activities on behalf of Takeda, as well as provides consultation to other Takeda entities (TCAL, PRD) relative to process improvements and policies on import and export compliance activities.
- Ensure that a trained staff is in place, new SOP s /guidelines/templates are written as needed and all procedures are consistent with current global regulatory requirements for Import/Export
- Develop and manage people and projects within established budgets. Responsible for performance management and career development for direct reports.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
- Bachelors Degree, preferred in Business, Science or Law
- Minimum 8 years experience in R&D material management/clinical supplies/logistics, including 4 years experience in importing and exporting in pharmaceutical industry.
- Strong understanding and experience with international trade compliance laws and regulations including but not limited to, imports, exports, economic sanctions, Harmonization Tariff system (HTS), country of origin, boycott laws and Free Trade Agreements.
- Expert knowledge of trusted trader programs including Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA)
- Export Compliance Officer certification
- MBA or Masters
- Import/Export auditing experience
- HAZMAT Certification IATA and IMDG
- Well developed supply chain knowledge
Knowledge and Skills:
- Clinical Supplies - thorough understanding of the clinical packaging and labeling process supporting R&D in the U.S and abroad. Thorough knowledge of the phases and processes within the clinical development environment
- Ability to manage and influence at all levels of management, both internal and external, across multiple regions.
- Demonstrated analytical, business planning and problem solving skills. Develops trend analyses and builds baseline of information with respect to CTM moves across all modes and trade lanes.
- Strong conflict resolution and negotiation skills. Ability to react and respond quickly to investigate and resolve problems.
- Ability to work well and manage others in a highly cross-functional and cross-regional team environment.
- Ability to manage internal and external resources (people, information, technologies, time and capital); allocates resources appropriately, given organization, group and individual goals and objectives to align with business imperatives.
- Ability to express one s self clearly and concisely to others, whether in person or via the telephone/email; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience. Coordinates and develops partnerships with key stakeholders to ensure effective communication and on-time delivery of CTM.
- Leadership Skills develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda s goals and objectives.
- Analytical and Problem Solving Skills -ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
- Teamwork -- the ability to work well and manage personnel in a highly cross-functional team environment.
- Budget Management - ability to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
- Communication Skills -ability to expresses one s self clearly and concisely to customers over the phone or with others within team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience
- Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
- Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
Resource Management -ability to manage internal and external resources (people, information, technologies, time, and capital); allocates resources appropriately, given organization, group and individual goals and objectives to align with business imperatives
- Requires approximately 10-15 % travel.
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