The role is part of the Software Delivery Service (SDS) team, which is an internal consulting group responsible for planning and supporting global teams executing system change projects (launch, modify, decommission). The Associate, Business System Consultant role performs many activities to help drive the project to completion, such as, but not limited to Software Lifecycle (SLC) SME, Project Coordinator, document author and handler. This is a very dynamic position that requires flexibility and creativity to succeed.

Responsibilities may include:

• Assess each project to determine approach and deliverables, then communicate to the project teams. 
• Guide new system assessments and documentation if needed.  
• Verify system and change characteristics.
• Determine the project costs.
• Provide document content review and guidance, and authoring as needed.
• Coordinate and manage Abbvie SLC deliverables, including oversight of technical writers to ensure documentation is correct and complete.  Documents may include but are not limited to project plans, change requests, validation plans, user requirements, functional requirement specifications, risk assessments, test plans, user acceptance test protocols, project summaries, where applicable.  
• Ensure documents are routed for review and approval in the documentation management tools.
• Close out all projects and transfers ownership to the Business/IT System Owner.
• Provide oversight and metrics on SLC services and vendor.
• Point of contact for cross functional activities with project teams, PM, other service delivery teams and technical writers.
• Report project status, progress, and issues on a regular basis. Escalate issues where appropriate.
• Regularly assess service processes and guide improvements.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Proactively seek out strategic business opportunities with business unit executives for the application of new service offerings.
• Conducts training and coaching.
• Identify process disconnects and translate them into improvement opportunities with cost savings or avoidance, productivity improvements, or revenue generating business benefits. Develops business relationships and integrates activities with other BTO's to ensure successful implementation and support of project efforts.
• Manages relationships between clients involved and BTOs to assure effective communication between the groups is occurring. Brokers services within BTS community on behalf of customers; coordinates system solutions.
• Allies with other BTS functional areas to remain current on project status, and inform customer management of progress; conversely, keeps BTS managers aware of user issues and resolves conflicts.
• Identifies the impact of any relevant statutory, internal, or external regulations on the organization's use of information.
• Exercises considerable latitude in determining objectives of assignment. Has defined authority and responsibility for a significant area of work, including technical, financial, and quality aspects. Establishes organizational objectives and delegates assignments. Accountable for actions and decisions taken by self and subordinates.
• Ability to coordinate their own tasks with deliverable dates and be hold accountable is important
• Host meetings and publish meeting notes
• Follow up on action items
• Accountable to plan activities and meet the delivery dates, including the final product

• Bachelor’s Degree with 6 years’ experience; Master’s Degree with 5 years’ experience; PhD with 0 years’ experience.
• Strong background in SDLC and Software Life Cycle management.
• Excellent communication skills
• Leadership of technical professionals; proven effective leader to cross-functional teams with focus on qualification of systems
• Strong background in process improvement (i.e., Six Sigma, Lean Methodology).
• Experience with managing vendors.

Additional bonus skills/experience

• Project Coordination
• Experience with GxP regulations, internal policy/ procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11)
• Knowledge of Software Quality Assurance
• Working within a compliance framework