Mastering Project Management in Pharma: A Strategic Approach to Contracting & Pricing without the mention of Sanofi

Introduction

Introduction and Definition of Project Management in Pharmaceutical Contracting & Pricing

In the demanding and intricate world of the pharmaceutical industry, project management embodies the strategic orchestration of tasks, resources, and objectives to facilitate the development, regulation, and delivery of healthcare products and services. More precisely, within the context of pharmaceutical contracting and pricing, project management assumes a pivotal role where multifaceted projects must align with stringent regulatory requirements, ever-evolving market dynamics, and complex reimbursement structures. It calls upon professionals to not just manage but to anticipate and innovate within the intricate lifecycle of drug pricing contracts and agreements.

The role of a Digital Functional-Technical Expert in Contracting & Pricing transcends conventional IT tasks—it is about architecting solutions that provide precise and compliant contracting and pricing strategies. These experts delve into the intricacies of government and Medicaid pricing, navigate through the nuances of specialty care, and adapt to the dynamics of general medicines, all the while working within the subtle gradations of the legal and regulatory frameworks. They are responsible for leading and executing functional and technical expertise throughout the digital solution lifecycle, ensuring that the principles of project management are meticulously applied to deliver value and maintain compliance in a highly digitalized and interconnected business domain.

The Role of Project Management in Daily Work

In today's milieu, project management is a linchpin for success, especially when you are a Digital Functional-Technical Expert, Contracting & Pricing. This position, oftentimes unseen in the spotlight of corporate acclaim, demands an acute understanding of the hyper-connected web of pharmaceutical operations—where tasks, resources, knowledge, and technological advancements intersect with the variations and uncertainties of daily work.

Modern project management is not simply about checkpoints and deliverables; it is increasingly about embracing past experiences while leveraging emerging tools and technologies. Contemporary employees, many a time from the digital-native demographic, shift the paradigm by advocating for smart work practices over traditional methodologies. They bring agility and a proclivity for disruptive innovation, integrating artificial intelligence, Internet of Things (IoT), and other emergent technologies seamlessly into their work ethos.

Key Components of Project Management

Effective project management within pharmaceutical contracting and pricing flourishes upon several key components:

1. Strategic Planning: Establishing a roadmap that aligns with both short-and long-term business objectives while maintaining compliance with healthcare regulations.

2. Resource Allocation: Efficient utilization of skills, tools, and budget to optimize the return on investment across projects.

3. Risk Management: Proactive identification and mitigation of potential risks associated with the complexities of contracting and pricing within the industry.

4. Communication: Ensuring clear, consistent, and transparent communication with all stakeholders, including internal teams and external partners.

5. Adaptability: The ability to shift strategies in response to regulatory changes, market conditions, and internal corporate realignments.

Key Challenges and Considerations

The sphere of contracting and pricing in pharmaceuticals presents several unique challenges:

1. Regulatory Compliance: Staying up to date with complex and changing regulations to avoid penalties and ensure market access.

2. Data Management: Handling vast amounts of sensitive data accurately, with stringent privacy and security measures.

3. Cross-functional Collaboration: Bridging gaps between departments such as legal, finance, sales, and IT for holistic project outcomes.

4. Technology Integration: Implementing and managing cutting-edge digital solutions that comply with industry standards and enhance business processes.

5. Change Management: Helping teams adapt to new workflows and technologies without disrupting existing operations.

Benefits of Project Management for a Digital Functional-Technical Expert

For the Digital Functional-Technical Expert in Contracting & Pricing, adept project management yields substantial benefits:

- Enhanced Compliance: Ensuring all projects adhere to the regulatory frameworks governing pharmaceutical pricing.

- Increased Efficiency: Streamlining processes to reduce cycle times and speed up the delivery of contracts and pricing agreements.

- Improved Accuracy: Reducing errors in pricing strategies, which can directly impact profitability and compliance.

- Informed Decision-Making: Leveraging project data and analytics to make strategic business decisions.

- Innovation Facilitation: Fostering an environment where new, technology-driven approaches to traditional challenges are welcomed and implemented effectively.

In essence, project management stands as a cornerstone of the digital expert's role—melding the granular technicalities of contracting and pricing with the broader corporate vision, ensuring that every initiative resonates with their company's strategic direction. Balancing the wealth of experience inherent in established professionals with the fresh perspectives of the newest workforce entrants, project management becomes the harmonizing force allowing for the convergence of distinctly different worlds. The outcome? Real solutions that bridge the gap between legacy operations and modern, disruptive possibilities, thus propelling the industry forward into a new era of pharmaceutical excellence.

KanBo: When, Why and Where to deploy in Pharmaceutical as a Project management tool

What is KanBo?

KanBo is a comprehensive project management tool that embeds the principles of Kanban and other agile methodologies into its design. It is structured to streamline workflows through visual management of tasks (cards) within boards (spaces) organized under projects or themes (workspaces). It is a digital platform that leverages cards, spaces, and boards to coordinate work, foster responsibility, and enhance transparency and collaboration amongst team members.

Why use KanBo?

KanBo is used to efficiently manage projects by providing real-time visibility of work progress, identifying bottlenecks, and facilitating effective communication across teams. It simplifies work coordination, allowing team members to focus on high-value activities, nurture a culture based on trust, and create a sense of shared purpose. By integrating with popular enterprise technologies, it also helps to maximize ROI and aligns closely with organizational infrastructure.

When to use KanBo?

KanBo should be employed when managing a complex project that requires clear visualization of tasks, deadlines, and dependencies. It is particularly useful for projects that are dynamic and might require frequent updating and re-prioritization of tasks, such as in a contracting and pricing scenario where negotiations and market conditions can change swiftly. It is also suitable for managing cross-functional teams or when working with remote or hybrid work arrangements.

Where to use KanBo?

KanBo is a versatile tool that can be used in various organizational environments, including on-premises or in the cloud. It integrates with popular platforms such as SharePoint, Microsoft Office 365, Google Suite, AWS, or Salesforce, making it suitable for businesses of all sizes and industries that prioritize technology harmonization and efficient project management.

Role of Digital Functional-Technical Expert, Contracting & Pricing in Project Management using KanBo:

In the pharmaceutical industry, a Digital Functional-Technical Expert involved in contracting and pricing can use KanBo for structuring contract development phases, tracking progress, and ensuring alignment with regulatory requirements. By using KanBo's features like Gantt Chart views for timeline planning, Forecast Chart views for progression tracking, and clear delegation of tasks (Responsible Person or Co-Worker), the expert can optimize pricing strategies, comply with agreements, and manage stakeholder involvement effectively.

Why should KanBo be used in Pharmaceuticals as a Project Management Tool?

The pharmaceutical industry faces unique challenges including stringent regulatory demands, complex stakeholder management, and the necessity for meticulous documentation and audits. KanBo offers solutions tailored to these needs:

1. Compliance: Ensures that all tasks and documentation meet regulatory standards through traceable workflows and transparent task management.

2. Collaboration: Facilitates teamwork and information sharing, essential for cross-functional tasks such as regulatory submissions and pricing negotiations.

3. Efficiency: Improves resource allocation, reduces cycle times, and helps in managing various contracts and their pricing models with ease.

4. Risk Management: Allows early identification of potential issues through Card Issues and Blockers, thereby enabling proactive risk management.

5. Adaptability: Supports various workstyles and can adjust to different project management methodologies that are prevalent in the pharmaceutical industry.

In summary, KanBo’s visualization tools, time management features, and customization options make it an ideal project management tool for aligning the intricate and highly regulated processes of pharmaceuticals with the efficiency and clarity required for success.

How to work with KanBo as a Project management tool in Pharmaceutical

Certainly! Here's an instructional guide for the Digital Functional-Technical Expert role detailing how to use KanBo for project management, including the purpose and explanation for each step.

Step 1: Define and Set Up Your Workspace

Purpose: To create a centralized location for your project that houses all relevant information and participants.

- Why: A dedicated workspace ensures that all team members know exactly where to find all project-related documents, discussions, and tasks. It is the first step to organizing your project and promoting easy navigation among your team.

Step 2: Plan Your Project Scope in a Space

Purpose: To visually represent the project’s workflow and scope.

- Why: Defining the project scope in a space helps in managing expectations, setting clear objectives, and allocating resources effectively. It also allows for a unified understanding of the project's boundaries and deliverables among all team members.

Step 3: Create Cards for Each Task and Subtask

Purpose: To break down the project into manageable pieces and assign responsibility.

- Why: Creating individual cards for tasks and subtasks ensures that every aspect of the project is accounted for and overseen. It prevents tasks from being overlooked and helps in tracking progress on a granular level.

Step 4: Set Dependencies with Card Relations

Purpose: To establish the order and dependencies of tasks.

- Why: Setting up card relations is crucial for understanding the flow of tasks and ensuring that critical path activities are prioritized. It helps in avoiding bottlenecks and synchronizing parallel tasks.

Step 5: Assign a Responsible Person and Co-Workers to Each Card

Purpose: To designate accountability for task completion.

- Why: Identifying a responsible person and co-workers for each card fosters ownership and clarity on who is accountable for what. This helps in maintaining individual responsibility and encourages proactive communication within the team.

Step 6: Schedule Tasks with Accurate Dates

Purpose: To create a timeline for your project.

- Why: Accurately scheduling tasks and milestones lays out a clear roadmap for project execution. It helps in ensuring that the project remains on track and deadlines are met while also allowing the team to prepare for upcoming tasks in advance.

Step 7: Monitor and Resolve Any Date Conflicts or Card Issues

Purpose: To manage and mitigate risks to the project timeline.

- Why: Actively monitoring for date conflicts and card issues allows for swift resolution of potential problems that could derail the project. Identifying and addressing these issues early maintains project momentum and reduces downtime.

Step 8: Visually Manage Project Progress using Gantt Chart View

Purpose: To get an overview of all project activities and timelines.

- Why: The Gantt Chart view provides a visual timeline of the project, helping the team to understand the sequence of tasks, their duration, and overlapping activities. This perspective is essential for forward planning and resource allocation.

Step 9: Analyze Work and Identify Bottlenecks with Time Chart View

Purpose: To improve process efficiency through detailed analysis.

- Why: The Time Chart view enables the team to track how long tasks take to complete and to pinpoint where delays happen. This analysis helps in identifying inefficiencies and implementing changes to streamline the project workflow.

Step 10: Forecast Project Completion with Forecast Chart View

Purpose: To anticipate project completion based on current data.

- Why: Using the Forecast Chart view provides projections for the project completion date, enabling the team to set realistic expectations and adjust plans accordingly if the project risks falling behind schedule.

Step 11: Communicate Effectively Within KanBo

Purpose: To centralize communication and ensure all team members are informed.

- Why: Ensuring that all communication regarding the project happens within KanBo keeps information accessible and traceable. It allows for better tracking of decisions and discussions, and supports transparency within the team.

By following these steps in KanBo, the Digital Functional-Technical Expert will be able to effectively manage and coordinate project tasks, while fostering a culture of responsibility and collaboration. Each step is designed to utilize KanBo's capabilities to enhance the project management process, streamline workflow, and ultimately lead to the successful completion of the project.

Templates for Project Management in Pharmaceutical

Certainly! Below is an example of a ready-to-use template crafted for project management in the pharmaceutical industry using KanBo features:

Name: Pharmaceutical Product Development Flow

Challenge and Business Objective:

Challenges & Objectives:

- Manage the complexity of developing a new pharmaceutical product through various stages of research, testing, and approval.

- Adhere to strict regulatory standards and timelines.

- Foster collaboration among cross-functional teams, including research, clinical trials, regulatory compliance, and marketing.

- Deliver a market-ready pharmaceutical product that satisfies business objectives in terms of safety, efficacy, and profitability.

Features to Use in Everyday Use:

Workspaces: Create a dedicated workspace for the product development lifecycle to help coordinate efforts across various departments.

- Spaces: Establish spaces for each major phase like Research, Pre-Clinical Trials, Clinical Trials, Regulatory Approval, and Market Launch.

- Cards: Use cards to represent tasks such as literature review, formulation development, IND application, clinical study design, marketing plan, etc.

- Card Relations: Establish parent-child relationships for tasks that have dependencies.

- Card Status: Implement custom statuses to reflect phases such as Pending, In Progress, Review, Approved, and Completed.

- Responsible Person: Assign a lead researcher, trials manager, regulatory specialist, and marketing lead as responsible persons for their respective cards.

- Co-Workers: Add team members who support specific tasks within the cards.

- Date Conflict: Monitor for overlapping due dates between critical regulatory milestones and internal deadlines to resolve potential scheduling conflicts.

- Card Blockers: Identify and categorize blockers such as pending approvals or trial delays that may hinder progress.

- Gantt Chart View: Gain a visual overview of the entire project timeline, tracking parallel and sequential tasks across stages.

- Time Chart View: Understand how much time is spent at each stage to optimize the development process.

- Forecast Chart View: Use historical velocity and progress data to predict project completion dates and adjust plans accordingly.

Benefits for the Organisation, Manager, Team:

- Organisation: KanBo helps pharmaceutical companies optimize their product development pipeline, ensuring projects remain on track to hit critical regulatory deadlines, and product launch targets. The result is reduced time to market and improved return on investment.

- Manager: Managers gain a comprehensive project view, enabling them to oversee progress, identify bottlenecks early, and allocate resources more effectively. They also have enhanced ability to communicate progress to stakeholders and maintain documentation needed for regulatory compliance.

- Team: The team benefits from clear task assignments, visible workflows, and deadlines. The workflow transparency reduces uncertainty about priorities and responsibilities, fostering team collaboration and enabling members to focus on high-value activities.

As a Response to the Challenge and Business Objective:

KanBo's capacity to integrate and streamline complex processes aligns perfectly with the precise, multitiered demands of pharmaceutical product development. The workspace creates a unified, collaborative environment, while sophisticated tracking and forecasting tools allow teams to anticipate challenges and adapt strategies promptly. This template response to the main challenge by promoting clarity, ensuring regulatory adherence, and enhancing overall team productivity—all critical components for transforming strategic objectives into successful pharmaceutical products.

Glossary and terms

Glossary

Introduction

Navigating complex projects and workflows is made easier with the help of digital tools that provide structure and tracking. With various features that allow teams to organize, manage, and analyze tasks, understanding the terminology used by these tools is crucial. This glossary aims to break down the jargon into digestible explanations, equipping users with the knowledge to effectively utilize project management systems.

- Workspace:

- A collection of related spaces designated for a particular project, team, or subject area that consolidates essential collaborative areas for ease of access and organization.

- Space:

- A conceptual area within the system where cards are organized, representing different projects or sections and serving as a platform for teamwork and management of tasks.

- Card:

- The basic unit within a space, acting as a placeholder for tasks or items. Cards hold important data including comments, attachments, deadlines, and interactive checklists, and can be tailored for various scenarios.

- Card Relation:

- Defines the dependencies between cards, illustrating how tasks connect and impact one another. Card relations help in breaking down larger tasks into manageable units and establishing task sequences.

- Card Status:

- A label that identifies the state of a task, such as 'To Do' or 'Completed,' allowing for a quick assessment of progress and aiding in the overall organization of work.

- Responsible Person:

- The individual tasked with overseeing the completion of a card. They are accountable for the progress and completion of the associated task and the point of contact for any relevant questions or issues.

- Co-Worker:

- A team member who contributes to the execution of a task associated with a card. Co-workers collaborate to achieve the objectives set forth by the card's details.

- Date Conflict:

- Occurs when the due dates or timelines of related cards overlap or contradict, leading to potential scheduling complications and hindering task prioritization.

- Card Issue:

- Any problem associated with a card that interferes with its smooth management. Issues have unique visual markers, such as color coding, to aid in quick identification and resolution.

- Card Blocker:

- A specific type of card issue that represents an obstacle preventing a task from progressing. Card blockers are labeled and categorized to provide clarity on what is stalling a task.

- Gantt Chart view:

- A visual representation of tasks spaced out over a timescale. The Gantt Chart view helps in planning and tracking progress of complex, time-bound tasks or projects.

- Time Chart view:

- A visualization tool that tracks the amount of time taken to complete a task or a set of tasks in a workflow. It's useful for monitoring efficiency and identifying areas of delay.

- Forecast Chart view:

- A predictive model that charts out project progress and estimates completion times based on the rate of work completion. This view is valuable for projecting timelines and managing expectations.