Posted to MedZilla on 4/25/2017

Takeda Pharmaceuticals

US-IL, Senior Compliance Training Specialist 1700442-MZ


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!


The Senior Training Specialist is responsible for supporting all USBU Compliance-specific training programs and strategies. The role also supports all USBU business functions by assessing current training programs, measuring training performance, and collaborating with external functional areas to implement recommended training program adjustments.


Under the direction of the Associate Director, Compliance, this position will help the USBU Compliance organization develop launch and monitor compliance-specific training and communications programs for the USBU. The role will also help support the management of the governance, demand management, administration, and assessment of Non-GxP training for the entire USBU organization (all business functions)
Compliance-Specific training responsibilities:
  • Training Strategy/Approach
    • Assist in the management of the Compliance-specific training curriculum to be consistent with OIG regulatory guidance, IFPMA Code requirements and other applicable codes, laws, regulations and internal policies and procedures.
    • Perform an annual analysis, review and update, of compliance training to ensure consistency with USBU training strategies. Core strategic focus areas include: balancing training types, volume, and communications with a goal for awareness, access and adherence.
    • Assist in the development and implementation of a standardized evaluation process to measure curriculum standards and immediate training results, incorporating results into future training enhancements.
    • Collaborate with the Director, Compliance, on developing and implementing a Compliance Communication Program and annual plan.
  • Communication and Awareness Campaigns
    • Manage the content, logistics, and execution of various Compliance-related communication and awareness initiatives.
  • Content Review and Creation:
    • Assist in the management the design and development of compliance training deliverables, to align with the Compliance training strategic direction/vision, as well as industry research, best practices, and USBU needs.
    • Assist to identify and develop compliance training using a variety of instructional techniques and formats (e.g., e-learning courses, teleconference/webex trainings, PowerPoint presentations).
    • Review training materials for other functional areas for compliance with internal/external policy, law and regulation requirements.
  • Business Insights:
    • Manage and build a collaborative network of relationships with other functional areas to identify areas of risk or compliance knowledge deficiency and develop Compliance training improvement recommendations.
    • Conduct analysis to identify business opportunities and needs, to determine learning solutions for relevant Compliance training and awareness topics.
  • Administration
    • Administer Compliance training courses in the appropriate Learning Management System (LMS). Review and communicate training performance on Compliance-specific training.
  • Document Management
    • Ensure all USBU Compliance Policies, Procedures, and other relevant documents have a change control governance process, are up-to-date, and posted to the appropriate repository.
  • Other responsibilities
    • Support the Global Compliance function on global training initiatives.Facilitate cross functional team meetings on a project-by-project basis.
    • Support other USBU Compliance initiatives at the direction of the Head of Compliance, USBU.
USBU Responsibilities:
  • Launch a periodic assessment of all training requirements for USBU employees through interviews, data analysis and other relevant methods. Develop recommendations for review at USBU Executive Leadership meetings concerning effectiveness, load, matrices, types, distribution, and completion performance. Implement approved recommendations.
  • Recommend a Non-GxP training governance model for the USBU; implement upon approval.
  • Liaise with other functional groups that create training requirements on USBU employees (Example GxP training requirements). Share consolidated USBU feedback concerning GxP training requirements placed on USBU employees. Collaborate on areas where opportunities exist to reduce training obligations or develop new channels for awareness and adherence.
  • Develop and administer a Non-GxP governance and document management process for all relevant Polices, SOPs, and other relevant documents.
  • Administer relevant training system(s) for Non-GxP training for all USBU employees. This includes assigning, monitoring and tracking course completions. Establish and maintain databases and training activity records compliant with Takeda s record retention requirement. Identify and analyze trends, produce statistical reports and make presentations to the senior management as directed by manager.
  • Create innovative communication methods to increase USBU employee awareness and adherence to training obligations.
  • Design, Develop and implement training awareness communications for USBU employees concerning pending training, active training, and late training. Provide on-site support for Training and Communications-related activities.
  • Launch additional training assessments and evaluations when required based on USBU Executive Team feedback.



  • Bachelor s Degree required
  • Five plus years training experience in healthcare or the pharmaceutical industry strongly desired.
  • Experience in training program design/development and evaluation required.
  • Experience working with Learning Management Systems (LMS) administration and processes
  • Experience in all aspects of instructional design/development process (analysis, design, storyboard, audio/animation, development, implementation, and evaluation).
  • Experience in developing work plans and project plans or strong project management experience required
  • Effective oral and written communication skills required.
  • Require proven ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions.
  • Effective oral and written communication skills required.
  • Require proven ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions.
  • Must be able to demonstrate effective presentation skills.
  • Must have computer proficiency and able to utilize MS Office software (e.g., MS Word, MS PowerPoint, MS Excel) at an advanced level

  • Some travel (up to 15%) to develop and deploy training and communications programs.

we are driven to improve people's lives

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