TiER1 Performance
TiER1 Performance
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Pharmaceutical Regulatory Compliance
Pharmaceutical Regulatory Compliance
My Role As a Contract Senior Instructional Designer:
My Role As a Contract Senior Instructional Designer:
Consulted with global pharmaceutical SMEs and stakeholders to strategize, design, and develop engaging, instructionally sound learning solutions for pharmaceutical/healthcare compliance program initiatives.
Partnered with a pharmaceutical company's Chief Ethics & Compliance Officer and Director of Ethics & Compliance to align learning initiatives with their compliance program's priorities. These initiatives focused on reducing regulatory risk and adopting a compliance mindset across Company roles, securing additional Tier 1 SOWs.
Worked with internal project managers, graphic designers, and programmers to ensure the project's scope and objectives were met and aligned with the project's development.
Business Problems, Learning Solutions, My Role, and Results
Business Problems, Learning Solutions, My Role, and Results
(Note: All my work involved designing and developing proprietary pharmaceutical compliance learning solutions.)
Business Problem #1:
Business Problem #1:
The company was growing rapidly and acquiring new people and products. As a result, it became necessary to ensure compliance with the company's standard policies, the federal laws and regulations governing them, and the consequences of noncompliance. Solution: Compliance Program Training Update and Microlearning Curriculum
Solutions: Compliance Microlearning Curriculum and Training Update
Solutions: Compliance Microlearning Curriculum and Training Update
Initiative 1: Design 10 microlearnings to be developed in Lectora. These compliance courses were to be approximately 10 minutes long and assigned to specific employees for completion. To validate and evaluate the training, they agreed to add xAPI to track data (e.g., who completed the course, how long the learner spent on a page, correct/incorrect answers, how long it took to complete the course, etc.).
Initiative 2: Updated 3 eLearnings due to company and role changes, terminology changes, and to improve the flow and purpose of these courses.
My Role in the Design & Development Process for Curriculum Microlearnings (10) & eLearnings
My Role in the Design & Development Process for Curriculum Microlearnings (10) & eLearnings
Served as a Lead Instructional Designer for a regulatory compliance curriculum initiative ($200K).
Wrote and/or updated 10 microlearnings and 3 thirty-minute eLearnings designed for Articulate Storyline or Lectora. These covered healthcare compliance topics and Company compliance policies.
Created a Microsoft Word microlearning storyboard template so a team of Instructional Designers could consistently carry standard design elements and wording throughout all 10 compliance-based microlearnings.
Wrote and designed 3 (of the 10) storyboards using company compliance policy information and a client-approved outline framework for the course.
Used closed-system AI to generate scenario-based assessments that apply knowledge to real-life compliance situations.
Designed content for 2 infographics with additional real-life situations and case studies to help learners recall key information. Graphic designers then created these.
Reviewed wireframe prototypes in Figma to ensure the images aligned with my vision and interactivity ideas. Program developers then built these courses in Lectora.
Reviewed, edited, and updated the microlearnings and 3 eLearnings to ensure content accuracy, proper functionality, and a consistent user experience.
Created change logs and tracked changes for the entire curriculum of 10 microlearnings.
Results:
Results:
The client was pleased with the updated microlearnings/eLearnings, and their positive feedback led to additional eLearning SOWs for more compliance-related learning solutions.
Business Problem #2:
Business Problem #2:
Because of a compliance-related violation, the company entered into a CIA with the U.S. Department of Health and Human Services Office of Inspector General to address specific regulatory issues. After the CIA took effect, the company would have a limited number of days to provide CIA training to all employees. They needed a course developed quickly so they would be prepared when the CIA became official.
Solution:
Solution:
Rapidly designed and developed CIA training content in Articulate Rise to support a company-wide implementation on a tight turnaround. This course would be assigned to all employees and updated annually for the duration of the CIA agreement (5 years).
My Role in the Design & Development Process for CIA Training
My Role in the Design & Development Process for CIA Training
Served as the sole Senior Instructional Designer in designing and developing an Articulate Rise course to support Company employees in implementing a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of Inspector General.
Worked with the SMEs to draft an outline. Initially, we planned to schedule working sessions for the SMEs to review the CIA content and draft the outline. I was to participate to provide learning and organizational suggestions. Instead, because of the SMEs' time constraints and unfamiliarity with the process, I created the outline structure and draft using the basic content provided. In retrospect, it would've been easier and faster if I had been provided with the CIA from the beginning. I could have sifted through the complex content without relying as much on stakeholder interpretation. However, the client was concerned about sharing sensitive information at that time.
Used Articulate Rise AI features to design relevant graphics, create custom blocks, suggest ways to simplify and convey the text, and generate applicable regulatory compliance knowledge checks and scenario-based assessments.
Completed the Articulate Rise course development shortly after the CIA was approved and signed. SMEs used the Review features to comment on changes across several course iterations until they were satisfied and approved the course.
Image generated in Articulate Rise for "Navigating the Path of Compliance" for a Corporate Integrity Agreement.
Results:
Results:
I completed the CIA course well within the time required to deliver it to the entire company, giving stakeholders peace of mind. Stakeholders thanked me for quickly designing and developing the Corporate Integrity Agreement (CIA) course, and they were pleased with my ability to take the CIA's complex compliance information and format it for employees in a meaningful, interactive way. They also liked the review process in Articulate Rise, the product's look, and its ease of use. They gave me two wonderful recommendations after completing this project.
My TiER1 Client Testimonials
My TiER1 Client Testimonials
"I have had the pleasure of working closely with Margie over the past few years on several compliance training projects ranging from instructor-led to eLearning. Margie is a tremendous professional with an outstanding background in instructional design and training development - regardless of the modality.
If you are in need of a strong, professional training partner (either as a consultant or full-time employee), please seriously consider Margie. The topic area does not matter, as she very quickly learns what is necessary and then produces excellent training that resonates. I look forward to the next opportunity to work with Margie as well! "
"I had the pleasure of working with Margie Bowling while she was at Tier 1, where she partnered with us to develop several compliance trainings. Margie was wonderful to work with and quickly became someone we could trust to understand what we were trying to accomplish and turn it into strong, meaningful content.
She always asked thoughtful questions to make sure she understood the audience, the objectives of the training, and the specific risks we wanted to address. The trainings she developed were well targeted to the roles receiving them and focused on practical, relevant risk areas.
One of Margie’s strengths is her ability to take complex topics and make them easy to understand without losing the substance or the key educational message. Her content was thoughtful, engaging, and practical, and she was always receptive to feedback and easy to collaborate with.
I really enjoyed working with Margie and would highly recommend her to anyone looking for a thoughtful, collaborative partner who knows how to build effective and engaging training."
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