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New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe and effective use of products for patients and healthcare providers globally. The Global Labeling Therapeutic Area group is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country’s local Labeling. This position is 100% remote.
As part of the Global Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director, the GLL is responsible for:
Developing, maintaining and, implementing Core Labeling for assigned products in line with internal standards and guidelines
Developing, maintaining and, implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements
Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products
Leading cross-functional teams to develop, review and approve Core and Local Labeling documents
Independently recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority
Providing information to Global Labeling Compliance, as needed, to support internal and external (i.e., Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
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
Proficiency in crucial labeling requirements worldwide
Contributing to the continuous improvements to the end-to-end labeling process, including labeling policies, procedures, quality, and system tools
Providing guidance and training to other Global Labeling Leads
Ability to lead cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the confidence to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling project.
Independent ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology.
Strong project management skills with the ability to handle multiple projects and prioritize work accordingly.
Proactive problem-solving ability with the ability to make appropriate. recommendations/decisions.
Tolerance for ambiguity and action-oriented.
Strong written and oral communication skills.
Attention to detail and accuracy.
Ability to influence and negotiate.
Bachelor’s degree in a scientific discipline. Advanced degree preferred (MS, PharmD, PhD).
Minimum of 5 years in labeling or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance) preferred.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.