Mastering Compliance: Navigating Risks and Building a Culture of Integrity in Healthcare Leadership

Introduction

Introduction: Navigating Challenges in Risk and Compliance Roles

Risk and compliance roles face a unique set of challenges in today's fast-paced and highly regulated environments. With mounting pressures to adhere to ever-evolving laws and standards, professionals in these roles must demonstrate agility and foresight. This article delves into these challenges, with a personalized focus on daily tasks within US Healthcare Compliance Policy and Patient Specialty Services strategies at Novartis.

Key Challenges:

1. Evolving Regulations:

- Constant updates to healthcare regulations require continuous learning and adaptation.

- Professionals must ensure compliance across multifaceted patient services, such as hub services and copay programs.

2. Alignment and Communication:

- Achieving an aligned understanding with business owners to effectively address compliance risks.

- Providing clear, actionable advice on mitigating risks during implementation stages.

3. Monitoring and Evaluation:

- Evaluating the effectiveness of risk mitigation strategies and documenting progress.

- Engaging leadership to maintain a comprehensive view of the organization's risk landscape.

Engagement and Collaboration:

- Stakeholder Collaboration:

- Work closely with Patient Services stakeholders to ensure strategies align with Novartis policies and CIA requirements.

- Proactively monitor trends in the healthcare environment to inform strategic decision-making.

- Leadership Development:

- Guide and develop future leaders, like the Associate Director, by fostering specialized ERC guidance throughout US Patient Services teams.

Culture and Leadership:

- SpeakUp Culture:

- Establish trusted relationships and promote an ethical, compliance-centric culture among Patient Services teams.

- Collaborate across therapeutic areas to ensure a holistic perspective on risks.

By addressing these challenges with strategic insight and strong collaboration, risk and compliance roles can significantly contribute to reimagining medicine and ensuring ethical decision-making at the forefront of patient-centric strategies.

Overview of Daily Tasks

Overview of Daily Tasks for Director, Ethics Risk & Compliance - Patient Services Advisor

US Healthcare Compliance Policy

- Shape and Clarify Policies: Develop a deep understanding of the US Healthcare Compliance Policy as it pertains to Patient Specialty Services strategies, such as hub services and copay programs applicable to all US affiliates, including Innovative Medicines, AAA, and Novartis Gene Therapies.

- Specialized ERC Advice: Provide expert advice in areas with high or emerging risks, like customer experience center design, to assess potential risks early on. Engage with business owners to align on risk perception and propose clear, actionable strategies for risk mitigation during implementation.

Engagement and Collaboration

- Leadership Engagement: Actively communicate with Patient Services leadership teams to present a comprehensive view of ERC risks within their strategies, focusing on key watch areas and successes.

- Stakeholder Collaboration: Work with Patient Services stakeholders by participating in governance processes to ensure that strategy execution adheres to Novartis policies, procedures, and CIA requirements.

Monitoring and Analysis

- Environmental Monitoring: Stay abreast of the evolving US healthcare landscape, enforcement trends, and compliance programs of peer organizations. Analyze these elements with a deep understanding of Medical and Market Access strategies and ERC policies to extract and disseminate valuable insights within ERC.

Team Leadership and Development

- Team Development: Lead and mentor the Associate Director, ERC Patient Services Advisor, providing them with the necessary guidance to support all US Patient Services teams effectively.

Strategic Collaboration

- ERC Stakeholder Engagement: Partner with other ERC entities, like Risk Management Oversight and Operational Controls, to align on handling innovative Patient Services strategies, conduct Investigations, Monitoring, and address risks effectively.

- Relationship Building: Cultivate trusted relationships across all levels within Patient Services, promoting a SpeakUp culture and fostering a positive environment for compliance and ethical decision-making in the pharmaceutical landscape.

Therapeutic Area Collaboration

- Holistic Risk View: Coordinate with Therapeutic Area General Managers and cross-functional leaders to construct a comprehensive risk overview across therapeutic area strategies. Deliver actionable ERC guidance and facilitate smooth transitions to the appropriate ERC stakeholders when necessary.

This role demands a proactive approach to managing compliance and risk while staying ahead of industry trends and changes. An ability to navigate complex healthcare policies and collaborate effectively with diverse teams is essential for operational success and maintaining a robust compliance culture.

Mapping Tasks to KanBo Features

KanBo Feature: Card Grouping

KanBo's Card Grouping feature helps organizations efficiently manage tasks by organizing cards based on specific criteria. This enhances task visibility, helps prioritize work, and makes it easier to track progress.

Steps to Set Up Card Grouping:

1. Access the Space:

- Navigate to the desired Space within KanBo where you want to apply card grouping.

2. Access Grouping Options:

- Click on the "Grouping" option usually available in the space menu.

3. Select Grouping Criteria:

- Choose the criteria by which you want to group the cards. Common options include:

- Status (e.g., To Do, In Progress, Done)

- Labels (e.g., High Priority, Low Priority)

- Assigned Users

- Due Dates

4. Customize the Grouping:

- Specify any further customization options, like the order of appearance or color-coding for better visualization.

5. Save the Configuration:

- After selecting your preferences, save the grouping configuration to apply changes.

Benefits of Card Grouping:

- Enhanced Organization: Easily visualize and manage tasks by grouping them under relevant categories.

- Improved Focus: Facilitates prioritization by distinguishing tasks using various filters.

- Streamlined Progress Tracking: By grouping by status or due date, project managers can quickly assess progress.

- Increased Efficiency: Simplifies the task management process reduces time spent searching for specific tasks.

- Customized Views: Provides flexibility to tailor views to the specific needs of different teams or projects.

Using Card Grouping in KanBo enhances collaborative task management by ensuring everyone has a clear view of their responsibilities and can work more effectively towards shared goals.

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Glossary and terms

Introduction to KanBo Glossary

KanBo is a versatile platform designed to enhance work coordination, providing a bridge between company strategies and their implementation in daily operations. This integrated software solution leverages deep integration with Microsoft products and offers a hybrid environment that meets a variety of organizational needs. Below is a glossary of key KanBo terms to help users understand and effectively utilize the platform.

Glossary

- KanBo: An integrated work coordination platform that connects organizational strategies with daily operations, offering tools for workflow management, task organization, and communication.

- Hybrid Environment: A feature allowing the use of both on-premises and cloud infrastructure for flexibility and data compliance. KanBo supports this approach, unlike traditional purely cloud-based SaaS applications.

- Customization: KanBo offers high customization levels for on-premises systems, allowing organizations to tailor the platform to their specific needs, which is a limitation in many traditional SaaS solutions.

- Integration: Deep embedding of KanBo into Microsoft environments such as SharePoint, Teams, and Office 365, ensuring seamless workflow across platforms.

- Data Management: In KanBo, sensitive data is stored on-premises for security, while other data is managed in the cloud, achieving a balance between security and accessibility.

- Workspaces: The top hierarchical tier in KanBo, used for organizing distinct areas like different teams or clients, further divided into Spaces and Folders.

- Spaces: Subsections within Workspaces, representing specific projects or focus areas. They house Cards, the basic task units.

- Cards: Fundamental KanBo units working within Spaces, representing tasks or actionable items, complete with details such as notes, files, comments, and to-do lists.

- MySpace: A personal workspace that helps users organize and manage their tasks within KanBo more effectively through customizable views and task arrangements.

- Resource Management: A feature in KanBo for optimizing resource allocation across projects and tasks, reducing conflicts, and gaining insights into costs.

- Resource Allocation: Assigning specific resources to projects or tasks for defined periods, adjustable at project or task level.

- Resource Types: Various categories of resources in KanBo, such as internal employees, external contractors, machines, and rooms.

- Resource Attributes: Characteristics that define resources, including work schedule, location, skills, cost rates, and role assignments.

- Time Tracking: Functionality allowing resources to log time spent on tasks, ensuring detailed assessment of project efforts versus planned allocation.

- Conflict Management: KanBo's capability to identify and resolve resource allocation conflicts due to unavailability, helping optimize project management.

- Data Visualization: Tools in KanBo that provide visual insights into resource allocation, potential bottlenecks, and overall workflow efficiency through dashboards and charts.

This glossary serves as a foundational reference to navigate and leverage KanBo for improved organizational efficiency and strategic goal realization.