Sr. Manager Regulatory Affairs
Deerfield, IL
Req ID 50616BR
Business Title
Sr. Manager, Regulatory Affairs
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
SUMMARY
Provides instructional design and training leadership for the Global Regulatory Affairs organization (Medical Products & Bioscience). Directs subject matter experts, stakeholders and vendors in the design, development and implementation of high-quality, relevant and sustainable blended learning solutions. In addition, drives the development and implementation of comprehensive (cross-functional, multi-regional) communications and change management plans associated with large-scale solution implementation programs and process improvement initiatives.
Partners with all levels of the organization to provide access to knowledge- and skill-building experiences in support of Baxter leadership and GRA functional competencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
•Ongoing collaboration with functional area leads to assess training needs and priorities
•Manage projects for the design, development, implementation and evaluation of training programs, including those supporting organizational change/improvement initiatives and those requiring use of external vendors
•Investigate, communicate, and support access to external training opportunities to meet identified training needs, including those supporting the GRAPV functional competencies
•Manage the training curricula and compliance tracking for functional areas within RA (MP, BioSci)
•Partner with SOP function to ensure appropriate integration of SOPs and CQPs into training modules
•Oversee RA New Hire Orientation Program
•Provide guidance to RA staff responsible for delivering instructor-led training
•Responsible for training program files, ensuring a state of inspection-readiness
•Address complex inquiries from auditors/inspectors into staff training records and assignments
•Assist in providing guidance to function to achieve and maintain a state of inspection-readiness regarding training records; work with Compliance function on training-related exception/nonconformance reports and audit responses.
•Assist in monitoring existing and new training technologies and standards across Baxter and within industry.
•Drive towards a global standard regarding training for function, including process improvements to workflow to increase operational efficiencies.
•Contribute to an environment that fosters learning, collaboration, trust, regulatory excellence, creativity and innovation
Job Requirements
QUALIFICATIONS
•Leadership experience in all stages of instructional design, change management & communications
•Demonstrated experience in designing and developing training programs supporting procedures, technologies, regulations, and complex organizational change initiatives
•Demonstrated experience working with diverse (e.g., geographically, cross-functionally) customer groups
•Demonstrated experience developing and managing blended and sustainable learning
•Demonstrated experience managing change initiatives from within a global organization
•Solid working knowledge of Microsoft Office software (Word, Project, PowerPoint, SharePoint and Excel), Adobe Acrobat and Visio
COMPETENCIES
•Effective customer-facing interactions
•Strong project management skills
•Internal and external influence and advocacy
•Effective risk management and contingency planning in a regulated environment
•Scientific/technical analysis and decision-making using data and metrics
•Skills supporting continuous process improvement
•Strong strategic planning and problem-solving skills
EDUCATION AND/OR EXPERIENCE
•Bachelor's Degree or equivalent in Life Sciences, Organizational Development or Communications
•Professional accreditation and/or minimum 5 years experience in instructional design, training management, and/or performance consulting
•Minimum 6 years experience in the biopharmaceutical/medical device industry
•Preferred: Knowledge of regulatory affairs activities, Experience with ISOtrain or other TDTS/LMS, Knowledge of industry-standard regulatory technologies (e.g. FirstDoc, RSS, etc.)
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.
