Best Practices for Balancing Medical Affairs Globalization with Local Requirements

Erin O'Hare

Medical Affairs teams communicate and generate medical evidence to help healthcare decision-makers make informed choices that improve patient health outcomes. With increasing digital and scientific innovation and availability of data, Medical Affairs teams are playing an increasingly important role as a strategic decision-maker, along with the Commercial, Market Access and Research and Development functions within pharma companies.

With increased globalization over the last decade, Medical Affairs teams are also becoming more global and commonly have Global, Regional and Country teams. There are several challenges truly Global Medical Affairs (GMA) teams face, including:

1. Uncoordinated Effort: Uncoordinated local and Global teams develop their own content and training, resulting in duplication of efforts and inconsistent messaging posing compliance risks to the organization.
2. Local Variation: Local variation in treatment guidelines and patient journeys makes it difficult for GMA teams to consistently and accurately address country-specific needs of healthcare professionals.
3. Incompatible Systems: Incompatible systems make it difficult to report internally and extract insights on the value and impact of the GMA organization.
4. Limited Local Awareness: Limited local awareness of relevant Global Medical systems, training and SOPs hinders local stakeholders from doing their jobs in accordance with Global standards.
5. Inconsistent Roles, Requirements and Training: Differing responsibilities and requirements by role and inconsistent training across Global, Regional and Country teams results in performance variances.
6. Limited Knowledge Sharing: Lack of knowledge exchange and best practice sharing across Global, Regional and Country teams limits potential for synergies and collective learning.

Global Medical Affairs organizations need to find the appropriate balance between Global efficiencies and Local requirements to create the most value for their organizations. Achieving an appropriate balance between Global and Local Medical Affairs processes, systems and tools produces a large return on investment for leading pharma companies. At Two Labs, we have identified 7 best practices that will help to achieve an optimal Global-Local Medical Affairs organization:

1. Create Global Medical Affairs Capabilities
2. Focus Local Medical Affairs Activities on Scientific Exchange
3. Harmonize Systems Globally
4. Enable Global Access to Relevant Systems, Training and SOPs
5. Develop a Communication Plan
6. Standardize Roles, Hiring Requirements and Training
7. Encourage Global-Local Knowledge Sharing

• Create Global Medical Affairs Capabilities. Core Medical Affairs capabilities such as Medical Operations, Medical Information, Medical Education, Scientific Content (e.g., Medical Information Letters, FAQs, slide decks) and Training should be streamlined and globally centralized. For example, Global Scientific Content and Training teams should ensure Global content and training are universally available in a single system that countries can access and adapt. Country teams may make updates to content with Global approval to account for local differences in regulations, epidemiology data, study data, guidelines, and product labeling. In some instances, Global content and training does not exist and as a result, countries are forced to develop it independently, and in silos from other countries; as a result, there is a high likelihood of inconsistent messaging (a major compliance risk), and duplication of efforts across the organization. To avoid these problems, country-level content and training should be developed in close collaboration with the Global Scientific Content and Training teams.
• Focus Local Medical Affairs Activities on Scientific Exchange. It is important to focus country-level Medical Affairs efforts on scientific exchange (the dissemination of written or verbal information that is truthful, accurate, and not misleading by or on behalf of a manufacturer about the use of a drug, device or biological product) due to the variation in treatment guidelines and the patient journey at the country-level. Medical Science Liaisons (MSLs) are responsible for conducting scientific exchange; they deliver and receive real-time scientific information from healthcare professionals. Country-level non-scientific exchange activities—including Medical review of materials, scientific content development, and administrative activities—can be regionalized or outsourced to a vendor to maximize the local Medical Affairs teams’ efforts on scientific exchange with healthcare professionals.
• Harmonize Systems Globally. Global and Local MA teams often use incompatible systems to collect and share information. When different systems (e.g. VEEVA, Excel, local dashboards and SharePoint) are used to capture insights it can be difficult for the organization to look collectively across countries and develop impactful reporting and action plans. In addition, a variety of local systems limit an organization’s ability to invest more effectively in a universal system that can be used across the organization. As a best practice, agile Global systems should be used and adapted quickly to meet Global and Local needs.
• Enable Global Access to Relevant Systems, Training and SOPs. The Medical Operations team should develop plans to ensure that stakeholders across geographies have access to relevant systems, training, and SOPs which they need to do their jobs effectively. A common pitfall across the industry is that Regional/Country teams are unaware of,or do not have access to these Global tools and as a result are unable to capitalize on the resources that are available to them resulting in sub-optimal engagement with the medical community. As a first step, companies should catalog relevant information by role and make it available across the organization.
• Develop a Communication Plan. As part of optimizing the balance between Global, Regional and Local medical activities, new systems, processes and tools will likely be rolled out globally. Countries may feel that they are being inundated with information while still being expected to do their jobs and as a result, it is important that there is bi-directional communication between the global and Country teams.Global needs to be responsible for developing a plan that is shared with countries detailing when key initiatives, processes and SOPs will be rolled out so that local teams can not only anticipate the upcoming change but understand why the changes are taking place. A best practice to implement are “heads-up” communications that will be sent to Country Medical Directors including a briefing document for critical policy changes, the context for the change and what will be required from their organization to implement the proposed change. Countries are also encouraged to communicate their needs and best practices in implementing the new changes with Global to ensure a timely and efficient transformation.
• Standardize Roles, Hiring Requirements and Training. Global and Local Medical Affairs stakeholders should work together to define standard Medical Affairs roles and responsibilities. If this is done correctly, a Medical Director in France will have similar responsibilities to the Medical Director in Germany. Hiring requirements should also be standardized so that education and experience levels for the same role are consistent across geographies. Role-specific training should be developed and deployed to ensure that after individuals are hired, they are trained consistently. Country Medical professionals can also be given the opportunity to do a rotation in a Global Medical role to broaden their global experience.
• Encourage Global-Local Knowledge Sharing. Knowledge sharing between Global and Regional/ Country teams allows teams to showcase their work and learn from each other. Effective channels for knowledge sharing commonly used by our clients are poster sessions, during which teams share their ideas via a poster presentation and others vote on the best poster. Additionally, the COVID-19 pandemic has brought Global teams together in a virtual environment; teams are congregating in virtual water cooler chats to create a sense of community.

Finally, there is no “one-size-fits-all” approach to achieving an optimal global-local Medical Affairs organization, and it is important to take into account local dynamics when globalizing. It takes time, especially in companies with well-established local teams where achieving an optimal balance often takes longer (3 years or more). However, achieving a more optimal global-local balance will make for more productive Medical Affairs teams that are able to operate cohesively well into the future.

Erin O'Hare, Principal at Two Labs​