Responsibilities:
Change Management Responsibilities:
⢠Responsible for execution and maintenance of an existing change management planĀ
⢠Consultant will adopt an existing change management plan built around Companyās current change management frameworkĀ
⢠Support the project team through finalization of design, planning and preparation of system deployment, and measuring post implementation progress.Ā
⢠Drive and oversee completion of key deliverables (e.g., stakeholder assessment outputs & actions)Ā
⢠Complete draft stakeholder analysis, verify assumptions, and revise current view to align. Prepare summary to inform the core team and management.Ā
⢠Business Case ā 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.Ā
⢠Document roles & changes per regulatory sub-departmentĀ
⢠Summarize RACI, create āchange statementā per functional group by identifying whatās changing or remains the same. Describe any resistance or barriers for change. Summarize level of buy-in and commitment per sub-department.Ā
⢠Confirm SOPs, work instruction updates, associates to be trained. Manage update of SOPs/WI, and coordinate with new process owner framework.Ā
⢠Partner with the training consultant to deliver comprehensive preparation for the system roll-out.Ā
⢠Ensure appropriate stakeholders/ associates are defined in training & comm. plans Confirm training attendees against current departmental staff lists.Ā
⢠Provides input on training designĀ
⢠Coordinate activities with dependent projects, including Product Lifecycle Management (PLM) and End to End Artwork (ARTi) which are led by Companyās 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.)Ā
⢠Communicate training and support plans to the department, supporting deployment readiness.Ā
⢠Communication and stakeholder edificationĀ
⢠Regulatory functional updates ā support core team members with slide preparation and participation in group meetings.Ā
⢠Poll groups periodically on project health vs team knowledge/ awareness according to change management plan.Ā
⢠Provide support for following meetings ā prepare materials, minutes & follow-upĀ
⢠Monthly RA Leadership MtgsĀ
⢠RA Stakeholder CommunicationĀ
⢠Change Agent MeetingsĀ
⢠Lead regular change management team meetings, ensure meeting outcomes are documented and schedule status is reflected in the full project plan.Ā
⢠Provides up-to-date information to the Business Lead, including elevating risks and issues.Ā
Change Management Deliverables:
⢠Updated and verified Stakeholder AssessmentĀ
⢠Business case and value defined in a deployment dashboardĀ
⢠Summarized RACIĀ
⢠Stakeholder Engagement & Readiness Review PresentationsĀ
⢠Detail SOP/ WI update planĀ
⢠Training logistics and communicationĀ
⢠Monthly RA Leadership Meeting Presentations and minutesĀ
⢠Change Agent Meeting presentations and minutesĀ
⢠Updated Change Management planĀ
Communications Management Responsibilities:
⢠SupportĀ
⢠Monthly RA Leadership MtgsĀ
⢠Change Agent MeetingsĀ
⢠Facilitation of Lunch ān Learn SessionsĀ
⢠Training CommunicationsĀ
⢠Launch preparationĀ
⢠Go-Live Email from Leadership TeamĀ
⢠Go-Live Talking Points for leadership and functional headsĀ
⢠Launch iNet ArticleĀ
⢠Thank You Leadership EmailĀ
⢠Lessons Learned preparation and facilitationĀ
⢠Core Team CelebrationĀ
RMO Communication Deliverables:Ā
⢠āWalking Deckā ā created for key stakeholders to be used as an elevator pitch to cascade information to impacted teamsĀ
⢠RMO iNet Page Launch (Key Benefits, FAQs, Video Demos, updates throughout project)Ā
⢠eBoards (Coming Soon, Training, Countdown/Successful Launch)Ā
⢠Functional Area RoadshowsĀ
⢠Functionality SpotlightĀ
Skills:
⢠3-5 years of experience leading change management projects; ability to incorporate existing knowledge into Companyās Change Management frameworkĀ
⢠Clear, concise communication skills written, presentations, verbalĀ
⢠Demonstrated planning skills: well organized, structured and able to support an existing planĀ
⢠General knowledge of biopharma/ regulatory affairs is nice to haveĀ
⢠Experience with Liquent Insight manager or another registration management system is helpful
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC