Guest Column | April 11, 2019

5 More Best Practices MSD Regulatory Affairs Used To Implement Strategic Sourcing Partnerships

By Panagiota (Pam) Rizos, Associate Director, External Operations, Global Regulatory Affairs & Clinical Safety, Merck & Co., Inc.


Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD)

In my first article, I described five best practices my group, External Operations, Global Regulatory Affairs & Clinical Safety, Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., undertook to effectively extend our organization’s capacity through strategic outsourcing to external partners. Here are the final five best practices, which focus on building a strong foundation with external partners.

6. Standardized Transition Process

The initial phase of a new partnership is critical in establishing a strong foundation of knowledge, setting agreed upon expectations, and building rapport. We collaborated with our partners and followed a tollgate transition approach of four key milestones: 1) Transition Design, 2) Training, 3) Hypercare, and 4) Business As Usual, with defined criteria for each tollgate.

During the transition design, an overview of the regulatory business process is provided to our partners. We initiate discussions on roles and responsibilities and KPIs and start to plan the training phase. Prior to training, the regulatory affairs business SMEs compile a training inventory and agenda, using standardized templates. These are used to ensure that our partners complete all required training and are, in fact, accredited prior to delivering services.

During the Hypercare phase, our partners start to deliver services with mentoring from our internal regulatory affairs SMEs. During this phase, it is also important to ensure that the resources at our partner meet the required skill requirements. If there are gaps in knowledge, they should be resolved in the Hypercare phase, either through additional training or through supplementing the resource pool with highly skilled team members. Once the partner is able to meet the agreed upon KPIs consistently and independently, they proceed to the Business As Usual phase.

7. Defined And Documented Oversight Structure

Even after achieving Business As Usual, it is important to conduct effective oversight and governance to ensure effective performance and risk management and drive continuous improvement. We follow a governance structure of four tiers – Functional, Operational, Management, and Executive – which includes regular joint meetings with our partners.  The Functional and Operational levels are focused on performance and risk management. The Management and Executive level governance forums are focused on strategic growth and continuous innovation.

Our oversight practices are documented in an oversight operations document agreed upon by us and each of our partners. This includes defined KPIs, escalation pathways, and a business continuity plan for each partnership. We implemented a standardized and consistent approach across our partnerships to ensure efficient operations and set and agreed to expectations that are feasible up front.

In addition to the governance meetings we have with our partners, we also have an internal monthly forum where we share best practices.

8. Relationship Building

Building a strong relationship with our partners is critical to the long-term success and growth of the partnership. Although our partners are based internationally, we invest in regular visits to generate face time and drive relationship building. We have also embedded team members from External Operations and other regulatory affairs groups at the partners’ sites to conduct local oversight and focus on relationship building.

We also recognize our partners’ achievements and encourage innovative thinking. During a challenge or issue, we collaborate to identify the root cause and seek to understand the partner’s point of view. It is important to be firm, provide candid and constructive feedback, and focus on resolution. But it is also important to support our partners and represent their voices internally, as appropriate. When the partner observes that it is being supported, it drives openness, transparency, and flexibility. This is also critical as it stops a finger-pointing mind-set and encourages a collaborative partnership.

9. One Team Culture

In outsourcing, the relationship consists of a client and a supplier. However, in order to advance a strategic partnership, bilateral engagement is necessary to drive a One Team Culture. We have taken several actions to drive this culture, including the use of branding at our partners’ sites. We have deployed approved branded materials that focus on the MSD vision, which our partners use at their sites to inspire and motivate their teams. We also established a recognition program in which the MSD regulatory affairs SMEs recognize our partners for going above and beyond in various categories, such as teamwork. We also engage in team-building activities.     

10. Learn And Improve Continuously

We implemented our Strategic Sourcing Partnerships one and a half years ago. We continue to learn every day. We have deployed bilateral surveys to collect feedback and identify opportunities we can continue to improve on. We also incorporate lessons learned in regular refreshes of our oversight operations processes and KPIs.

Effective strategic sourcing and successful partnerships are important in fulfilling our mission of improving the lives of patients around the world. These partnerships expand our capacity and deliver value through skilled capabilities, best practices, operating efficiencies, and innovation. By preparing the organization internally to take on strategic sourcing and implementing effective oversight and relationship management with our partners, we can truly maximize the value of our partnerships and better collaborate with our strategic partners to meet all our important goals.