Merck Global Labeling Fellowship Program

Overview: 

Global Labeling Therapeutic Area (GL-TA) is an organization in Global Regulatory Affairs and Clinical Safety (GRACS). The purpose of GL-TA is to drive labeling strategy and ensure high-quality and compliant labeling documents, which summarize the product information to support the safe and effective use of products for patients and healthcare providers. GL-TA is accountable for developing and maintaining labeling content for Core and US Labeling for marketed products, developing early (target) labeling for developmental products, and supporting development and maintenance of the EU Labeling and other country’s Local Labeling. A product’s labeling contains a comprehensive summary of scientific and medical information gathered during product development and throughout its lifecycle. All finished drug products must be labeled, as required by country regulations. Labeling, as approved by a Health Authority (HA), healthcare providers and patients understand product usage, safety, and efficacy.

This is a 2-year Fellowship. The Fellow will spend 6 months at Howard Law School, 6 months at FDA, and 12-months at Merck in GL-TA. The goal of this 12-month fellowship in GL-TA is to provide the Fellow the essential tools to become a poised labeling strategist with the experiences and opportunities to interact with subject matter experts and other regulatory professionals. The fellowship is based in Upper Gwynedd, Pennsylvania.

Who Are We: 

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world — and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

Fellow Responsibilities May Include: 

• Developing, maintaining, and implementing Core and US labeling in line with internal standards and guidelines, and assisting with the development and maintenance of Local Labeling (EU and most of world).

• Leading cross-functional labeling teams in collaboration with regulatory affairs, clinical safety, clinical research, and other functional areas within Merck to develop labeling strategies.

• Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements.

• Evaluating risks associated with Core or Local Labeling content, developing mitigation strategies, and appropriately escalating issues to Global Labeling management and the Global Regulatory team.

• Providing information to Global Labeling Compliance, as required, to support internal and external (i.e., Regulatory Authority) requirements and support audits/ inspections as a labeling subject matter expert.

• Developing and updating standard operating procedures (SOPs) and other departmental documents.

• Process improvement projects and other department specific projects.

• Contributing to the continuous improvements to the end-to-end labeling process, including labeling policies, procedures, quality, and system tools.