Job Description

Reference # : 18-01313Title : IT - NICHE
Location : Lawrence Township, NJ
Experience Level : Start Date / End Date : 02/23/2018 / 08/22/2018
Assignment Detail
Industry:Biotech/PharmaJob Category:Project Management
Job Description: Project Description

Product should only be distributed per the approved market filing. Distributing an out of compliance product variant may result in fines, recall, loss of approval, reputational risk etc. Supply complexity of multiple suppliers, manufacturing sites and methods, emphasizes the need to control product to market. Reliable controls will ensure the right product at the right place.

Progressively deliver processes and technical solutions to support Product Market Compliance (PMC) across the network between 2017 and 2020.

? End to End process definition between Regulatory, RST, QA and SC as it pertains to batch release
? Integrate Quality and Regulatory systems data into PMC Framework in SAP
? Create a portal within SAP for the RST team to enter implementation data
? Batch Traceability, Inventory Reconciliation and PMC reports
? Standardize usage decision in SAP from LIMS

Project Timing
The project is a long term project, up to 2 years.

The PM will deliver the following activities for this project:

? Contributes to planning, executing, controlling, and closing the Project to ensure the Project is delivered to scope and meets time, cost and quality objectives
? Utilizes GPS standards and methodologies to verify scope, schedule, budget, monitor and control
? Ensures business objectives and project benefits are identifiable, measurable, and realized
? Monitors and tracks project progress, and leads project team to successful on-time and on-budget delivery of project
? Change management strategy, planning and delivery
- Support execution of change management strategy and plan and work breakdown
- Define change metrics for the project and measure change effectiveness
? Stakeholder identification and management
- Collaborates with the Project Leader and internal stakeholders to manage expectations and mitigate risk
- Identify and analyze key stakeholders (influence/impact/support)
- Develop and implement stakeholder engagement activities
- Facilitate leadership alignment and develop leadership action plans
? Communications Delivery
- Develop project communications strategy, approach and plan
- Develop communications messaging and launch via pre-defined channels
- Deliver pulse checks/other surveys to measure awareness and effectiveness


? Organization ? Ability to manage multiple priorities and resources in a dynamic environment across various departments, and organize complex information.
? Judgment and Decision Making ? Considers the relative costs and benefits of potential actions to choose the most appropriate one.
? Critical Thinking ? Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Must possess initiative with strong analytical and problem solving skills.
? Attitude & Teamwork? Projects confidence tempered with humility. Must be a team player willing both to steer the team towards success and to fully support the team when others are steering.
? Problem Sensitivity ?Ability to tell when something is wrong or is likely to go wrong. Recognizes there is a problem and escalates or informs the resources who can address the problem.
? Making Decisions and Solving Problems ? Analyzes information and evaluates results to choose the best solution and solve problems.
Additional Job Requirements:

Application Instructions

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