Regulatory Affairs Operations Specialist (Training)

Regulatory Affairs Operations Specialist (Training)

Deerfield, IL

Req ID 49614BR

Business Title
Regulatory Affairs Operations Specialist (Training)

Business
Medical Products

Sub-Business
Regulatory Affairs

Country
US

State/Province
Illinois

Location of Position
Deerfield, IL

Shift_
1st

Job Description
Under the direction of the Instructional Design & Communications team leader, coordinates instructional design, training delivery, and communications activities required to implement and maintain solutions supporting Baxter's Regulatory Affairs' operations. Partners with stakeholders, subject matter experts, and external instructional design resources to design, develop, implement, evaluate and sustain training and communication programs.
This position is for the Instructional Design & Communications unit within the Regulatory Information Management Team, which resides within the Regulatory Operations & Compliance organization.

•Conduct training needs assessments, training effectiveness evaluations and other activities with stakeholders, subject matter experts, trainees and others as appropriate to define new/revised training programs

•Provide and subsequently coordinate execution against project plans for assigned training and communications projects, including identifying and taking action to address risks; ensure integration of training project plans into master project plans for multi-part initiatives (e.g., system implementations/upgrades)

•Design, develop and implement courseware for in-sourced training projects

•Liaison with contracted external instructional design resources to execute against plan for assigned training projects

•Qualify internal would-be trainers per Corporate Quality Training requirements, and facilitate training program-specific train-the-trainer workshops and related activities

•Deliver instructor-led training in both traditional and virtual settings as assigned

•Generate and participate in the control of training program records and other official documentation

•Assist in monitoring existing and new training technologies and standards across Baxter and within industry

•Support the drive towards a global standard regarding training and communications supporting Regulatory Affairs' operations, including process improvements to workflow to increase operational excellence

•Contribute to an environment that fosters learning, collaboration, trust, regulatory excellence, creativity and innovation

Job Requirements

•Experience in instructional design (assessment, design, development, implementation, and evaluation)

•Experience in training solutions supporting IT system implementations

•Experience working on training projects involving external/contractor instructional design resources

•Demonstrated application of change management techniques, especially in the context of diverse (e.g., geographically, cross-functionally, generational, etc.) customer groups

•Solid working knowledge of Microsoft Office software, Adobe Acrobat, Visio, at least one instructional design authoring tool, and at least one training documentation tracking and/or learning management system.

•Effective customer-facing interactions

•Effective project management skills

•Risk management and contingency planning in a regulated environment

•Scientific/technical analysis and decision-making using data and metrics

•Skills supporting continuous process improvement

•Effective strategic planning and problem-solving skills

•Bachelor's degree or equivalent in instructional design, communications, education, organizational management, or similar

•Professional accreditation and/or minimum of 3 years experience in instructional design, training solution management, and/or performance consulting Preferred:

•Conversant knowledge of the regulatory affairs discipline and the healthcare product industry

•Experience with ISOtrain

Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.