Merck Regulatory Digital Health Fellowship Program


Merck & Co., Inc. ,in partnership with Howard University, is introducing an innovative fellowship program tailored for driven pharmacy graduates who aspire to lead at the convergence of digital health, law, and policy. This 2-year fellowship is meticulously crafted to deliver a comprehensive educational and professional journey, laying a robust groundwork for a prospective career in the pharmaceutical industry, with a specific focus on digital health, its use as a standalone tool and in combination with other medical devices. The Fellow will embark on a multifaceted journey, encompassing specialized courses in pharmaceutical law at the esteemed Howard University School of Law, hands-on experience in federal policy development at the U.S. Food and Drug Administration (FDA), and immersive exposure to regulatory strategies within our company. The fellowship’s structure is designed to evolve with the Fellow’s growth, commencing with a curriculum-focused learning experience, transitioning to targeted professional development, and culminating in assisting in the hands-on development of projects in digital health technology within our company.

Who We Are: 

Our company is a global leader at the intersection of pharmaceuticals and digital health. With a relentless commitment to innovation and patient care, we leverage cutting-edge technology and scientific expertise to develop life-changing solutions. Our diverse portfolio spans across pharmaceuticals, allowing us to address the evolving needs of healthcare worldwide. By integrating the latest advancements in digital health with traditional offerings, we strive to improve patient outcomes, enhance access to care, and drive the future of medicine.

The Regulatory Digital Health (RDH) department engages with enterprise leaders across our company to support policy management and the regulatory strategy of digital health tools (DHTs) and software medical devices (SaMD). In preclinical, RDH partners with functional leaders and teams within Translational medicine, Global Clinical Operations team (GCTO) and Business Development  to assess the operational and regulatory capabilities of DHTs and SaMDs, identify regulatory risks and requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs, GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical trials. Finally, in the post-market commercial landscape, RDH works with our Human Health division to evaluate and support DHTs/SaMDs that support healthcare providers and our patients.

Required Education: 

  • Planned graduation with PharmD prior to start of fellowship. 

Preferred Experience and Skills: 

  • Demonstrated leadership capabilities and initiatives.
  • Awareness of DHTs and their application to drug development and marketed biopharmaceutical products. 
  • Must be willing to learn and grow their knowledge in the global regulatory requirements landscape for drugs and DHTs for both new product development for initial registration and maintenance of registrations.
  • Excellent written communication skills, able to modify and adapt as necessary for the audience. Including internal strategy documents, clinical and market application documents and internal consultation.   
  • The ability to collaborate with global teams in the assessment, implementation, and training of new and revised global guidance and policies.
  • Proven ability to effectively manage and prioritize tasks to ensure timely project completion, while effectively communicating potential challenges and solutions to leadership and team members.
  • Experience gained through APPE rotations or internships, ideally with exposure to pharmaceutical industry stakeholders or regulatory bodies such as the FDA, contributing to a foundational understanding of the pharmaceutical industry.

Fellow Responsibilities May Include: 

  • Immersion into the strategic vision and planning of new digital health initiatives that establish operational processes and systems to fully incorporate DHTs into our company’s way of working across the broad product portfolio. 
  • Develop and deliver global regulatory DHT landscape maps to help identify and communicate emerging trends, regulations, and pending changes impacting products, while supporting digital health initiatives and guideline creation to streamline regulatory processes.
  • Support communication, assessment, implementation, and tracking of new global regulatory policies, while conducting assigned policy reviews to enhance organizational risk management initiatives, including offering audit/assessment support.
  • Develop skills in relation to business acumen, stakeholder management, communication, and influencing skills and ability to manage conflict. 
  • Learn how to build and manage new processes for facilitating resources to support global activities and key initiatives.
  • Work with global regulatory teams and policy execution teams to incorporate digital health perspectives impacting product development and share leading practices for teams to incorporate into their regulatory strategies.