(Remote) Senior Specialist - Labeling, Regulatory Affairs (Infectious Disease and General Medicine) ( MERCUSR157592ENUS)
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
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.
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
recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority
Project management skills with the ability to handle multiple projects and prioritize work accordingly.
Tolerance for ambiguity and action- oriented.
Strong written and oral communication skills
Attention to detail and accuracy.
Ability to influence and negotiate.
Ability to distill an issue into critical components and suggest solutions
Bachelor’s degree in a scientific discipline is required. Advanced degree preferred (M.S., Pharm.D, Ph.D.).
Minimum of 3 years of labeling experience 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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.
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Flexible Work Arrangements:Remote Work
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Number of Openings:1