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Bausch Health used Traditional Project Management for the project “EC Authorized Representative Change for BREXIT”. The decision to utilize traditional project management was since the needs of this project were clearly defined before planning, implementation, estimation and control of project related activities (Mrsic, 2017). The approach to use traditional waterfall methodology for this project was mainly due to the project changes being small but legally considered to be big. The applied technique would ensure that the project gets accomplished in the estimated period and accomplish the required success criteria by ensuring that the allotted budget does not go overboard. Planning, Execution, Implementation and Closing are the four stages that this project covers for successful completion.

BREXIT has caused Bausch Health to prioritize this project over others running parallelly as this project will impact international business and profits. The BREXIT project is to change the existing EC Representative from United Kingdom to Germany in order to continue uninterrupted business in the Europe. The timeline for this project’s completion is approximately a year. Once the Change of EC Representative is performed in Bausch Health, this will aid in maintaining our business activities in Europe and not have any impact in the revenue and profits before BREXIT kicks-in.

The stakeholders and SMEs were tasked to identify the risks that can occur looking at similar or past projects for success. The major stakeholder for this project is regulatory affairs. It is challenging because the implementation has to be performed before BREXIT can go live and, in a way, that we comply to EU regulations. Some of the risks that we managed to identify as a part of this exercise was the time constraint, label printing corrections, qualified resources, submission response time and new EC Representative agreement guidelines.

Planning is important to understand the objectives of the project for success. As a part of this, it is also important to simplify the scope and create a task list for the project (ProjectManager.com, Inc., 2019). The Project Planning for EC Representative Change will include determining the true scope of the project which will include Vision care and Surgical care products and collecting project artifacts to understand the project requirements. A project tracker will also be created as a part of planning to ensure that the products are captured and traced as required. The Project plan, project schedule, budget and cost approval for the project from the stakeholders will be conducted as a part of project planning as well.

Project execution is to put the project’s resources into action to achieve the organization’s goals. Project Implementation is the phase where plans from the previous phases are put into action (Orangescrum, 2019). For a change to take place in a company, an execution is necessary. Similarly, for the EC Representative to take place at Bausch Health, an execution of a series of regulatory activities and label production is required. This execution would include activities like finalizing strategy with notified body, approval of master QCRs, assess regulatory impact, update quality agreements and register new Authorized Representative. Following this, there will be change notification sent to the Notified Body, updating RA documentation and notifying international countries by notifications. Along with this execution, there will be a gate review in order to receive approval from senior management which will qualify as a project controlling process. This will ensure that all the processes are monitored to ensure there is no scope creep and to track everything to ensure the implementation is smooth (Orangescrum, 2019).

The project manager for the EC Representative project is in charge for recording all the changes and variations that can come up at the time of implementation. Observed changes should be sent to the project manager so that it can be escalated, and solutions can be found. The person responsible for this would be the project manager. This needs to be completed by the time gate review is performed.

In the last phase, which is project closing, the final formalities are completed. This stage is to ensure all labeling changes are complete with international notifications. Here, the project needs to be signed-off by the stakeholders to ensure that they acknowledge the successful completion of the project. The Master Quality Change Control needs to be formally closed which would mark the closure of the desired change of this project and the formalities have been executed. Once, all the deliverables are met, this project is still incomplete without project closing and the project manager needs to complete this procedure to mark the end of this project (Simplilearn, 2019).

If agile methodology is used for the Change in EC Representative project, this technique will allow us to work on this project by distributing the project in stages in association with the stakeholders. The Agile Methodology works by gaining insight about the delivery of the project through the clients. The clients provide the requirements that would help achieve the product that they expect with quality (Sacolick, 2018). It is always said that agile methodology is the best project management technique to use for projects and is trending in the market as the project manager is able to understand the customer/client expectations. Hence, the project manager is able to make necessary adjustments to project development to achieve the desired final product by executing the process in multiple cycles by keeping in mind the product needs of the customer. Project managers and stakeholders collaborate in Agile methodology in order to get the best project results. This also brings about quality results through testing and conducting project control procedures.

Agile Framework can be applied to a portion of the Change in EC Representative project for Bausch Health as waterfall method is preferred given the set of deliverables and milestones. The technique of agile will be helpful in the labeling change process which has various stages (Sacolick, 2018). This method can be improvised using agile as it can prevent or minimize the error during printing labels. This change is critical to the organization as it is critical for maintaining business and profits. This label change using agile technique will enhance the process and expedite the labeling production process and approval. By using Agile methodology, the company can enhance the effectiveness of the label precision and increase the process timeline, approval from stakeholders in a brief interval of time.

If Allied with Scrum is applied to Change of EC Representative project as a project management methodology for Bausch Health, the project manager will have to divide the resources of the team into small groups and each of these groups will be controlled by a Scrum Master who have the expertise in delivering procedures and methods that can be utilized in order to reduce or eliminate the identified risks (Sacolick, 2018). The project manager must also ensure that may affect in implementation of the EC Representative Label changes to safeguard that the project is finished in the stipulated planned timeline. Application of Agile with Scrum if used with the Change in EC Representative project, the project tasks would have to be conducted in short cycles which is also known as sprints. As this project is well suited for waterfall methodology, if Agile with Scrum is used, this can only be applied to the Implementation Phase. This implementation phase would mainly include Label Production Changes. While performing this, the teams can talk about the risks and tasks. They can collectively also find a way to resolve them for success (Sacolick, 2018).

In this particular project, the strategic financial management was very critical as this determines the fate of the project and it is also essential for success. For the BREXIT project, strategic financial management is important as this made us jot down the objectives of this project towards the beginning and to estimate the number of resources that would be needed to fulfil the goals of the project. This management and planning will also help us to utilize the existing financial reserve and additional capital funds so that the strategic objective of this project of changing EC Representative for BREXIT is achieved (Thibodeaux, 2019).

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Similarly, organizational awareness is a similar component that was required for this project. This awareness will aid in recognizing the right stakeholders who are reliable and have the potential to show a positive impact on this project and pave its way to success. Appropriate project and executive leadership is crucial as it brings in a sense of capability and expanding social network which can be useful in this particular project, like a project manager who can help Bausch Health be successful in achieving Change in EC Representative to achieve the goal of compliance to BREXIT by complying to EU regulations and maintaining uninterrupted business (Thibodeaux, 2019).

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References Mrsic, M. (2017, May 17). activecollab.com/blog/project-management/traditional-project-management. Retrieved November 29, 2019, from Traditional Project Management: https://activecollab.com/blog/project-management/traditional-project-management Orangescrum. (2019). Execution In Project Management. Retrieved November 29, 2019, from www.orangescrum.com/tutorial/introduction-to-project-management/execution-in-project-management: https://www.orangescrum.com/tutorial/introduction-to-project-management/execution-in-project-management ProjectManager.com, Inc. (2019). The Ultimate Guide to Project Planning. Retrieved November 29, 2019, from www.projectmanager.com/project-planning: https://www.projectmanager.com/project-planning Sacolick, I. (2018, March 15). What is agile methodology? Modern software development explained. Retrieved November 29, 2019, from www.infoworld.com/article/3237508/what-is-agile-methodology-modern-software-development-explained.html: https://www.infoworld.com/article/3237508/what-is-agile-methodology-modern-software-development-explained.html Simplilearn. (2019, October 4). How to Close a Project? Retrieved November 2019, 2019, from https://www.simplilearn.com/how-to-close-a-project-article: www.simplilearn.com/how-to-close-a-project-article Thibodeaux, W. (2019). The Relationship Between Strategic & Financial Planning. Retrieved November 29, 2019, from smallbusiness.chron.com/relationship-between-strategic-financial-planning-21063.html: https://smallbusiness.chron.com/relationship-between-strategic-financial-planning-21063.html