Responsibilities:
Change Management Responsibilities:
• Responsible for execution and maintenance of an existing change management plan
• Consultant will adopt an existing change management plan built around Company’s current change management framework
• Support the project team through finalization of design, planning and preparation of system deployment, and measuring post implementation progress.
• Drive and oversee completion of key deliverables (e.g., stakeholder assessment outputs & actions)
• Complete draft stakeholder analysis, verify assumptions, and revise current view to align. Prepare summary to inform the core team and management.
• Business Case – Work closely with Business Lead and Business PMO to gather value statements per functional group. Consolidate the feedback and verify value/ benefits anticipated with the team. Use this material to update the future state vision description. Create deployment metrics report or dashboard that will demonstrate the success of the project and system use.
• Document roles & changes per regulatory sub-department
• Summarize RACI, create ‘change statement’ per functional group by identifying what’s changing or remains the same. Describe any resistance or barriers for change. Summarize level of buy-in and commitment per sub-department.
• Confirm SOPs, work instruction updates, associates to be trained. Manage update of SOPs/WI, and coordinate with new process owner framework.
• Partner with the training consultant to deliver comprehensive preparation for the system roll-out.
• Ensure appropriate stakeholders/ associates are defined in training & comm. plans Confirm training attendees against current departmental staff lists.
• Provides input on training design
• Coordinate activities with dependent projects, including Product Lifecycle Management (PLM) and End to End Artwork (ARTi) which are led by Company’s Manufacturing (PO&T) organization. Also integrate training or processes necessary with other regulatory systems: dossier links (BREES), document links (BEAMS), and submission plans (MS Project Online).
• Support training logistics (reserve rooms, print materials, send/update meeting invite, training records are maintained (BIIB University), etc.)
• Communicate training and support plans to the department, supporting deployment readiness.
• Communication and stakeholder edification
• Regulatory functional updates – support core team members with slide preparation and participation in group meetings.
• Poll groups periodically on project health vs team knowledge/ awareness according to change management plan.
• Provide support for following meetings – prepare materials, minutes & follow-up
• Monthly RA Leadership Mtgs
• RA Stakeholder Communication
• Change Agent Meetings
• Lead regular change management team meetings, ensure meeting outcomes are documented and schedule status is reflected in the full project plan.
• Provides up-to-date information to the Business Lead, including elevating risks and issues.
Change Management Deliverables:
• Updated and verified Stakeholder Assessment
• Business case and value defined in a deployment dashboard
• Summarized RACI
• Stakeholder Engagement & Readiness Review Presentations
• Detail SOP/ WI update plan
• Training logistics and communication
• Monthly RA Leadership Meeting Presentations and minutes
• Change Agent Meeting presentations and minutes
• Updated Change Management plan
Communications Management Responsibilities:
• Support
• Monthly RA Leadership Mtgs
• Change Agent Meetings
• Facilitation of Lunch ‘n Learn Sessions
• Training Communications
• Launch preparation
• Go-Live Email from Leadership Team
• Go-Live Talking Points for leadership and functional heads
• Launch iNet Article
• Thank You Leadership Email
• Lessons Learned preparation and facilitation
• Core Team Celebration
RMO Communication Deliverables:
• “Walking Deck” – created for key stakeholders to be used as an elevator pitch to cascade information to impacted teams
• RMO iNet Page Launch (Key Benefits, FAQs, Video Demos, updates throughout project)
• eBoards (Coming Soon, Training, Countdown/Successful Launch)
• Functional Area Roadshows
• Functionality Spotlight
Skills:
• 3-5 years of experience leading change management projects; ability to incorporate existing knowledge into Company’s Change Management framework
• Clear, concise communication skills written, presentations, verbal
• Demonstrated planning skills: well organized, structured and able to support an existing plan
• General knowledge of biopharma/ regulatory affairs is nice to have
• Experience with Liquent Insight manager or another registration management system is helpful