Merck Global Labeling Lead, Associate Director (REMOTE) in Helena, Montana
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
“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 ensures 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 Director or Sr. Director of Global Labeling Therapeutic Area , the GLL is responsible for:
developing, maintainingand,implementing Core Labeling for assigned products in line with internal standards and guidelines
developing, maintainingand,implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
assistingwithdeveloping and maintaining LocalLabeling(EU and most of world) for assigned products
providingregulatory expertise and guidanceto teams while ensuring compliance with applicable regulatory requirements
serving as regulatory labeling expert on global Regulatory Affairs sub-teams to ensure regulatory labeling requirements are met, quality and compliant labeling documents, and timely regulatory submissions for assigned products
leadingcross-functional teamsto develop, review and approveCore and Local Labeling documents.
independently recommendingstrategies and labeling language for inclusionin Core or Local Labeling during labeling development or responses to Health Authority.
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.
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 inkeycruciallabeling requirements worldwide
contributing to the continuous improvements to the end-to-end labeling process,including labeling policies,processes, quality, and system tools.
providing guidance and training other Global Labeling Leads
Bachelor’sdegree in a scientific ormedically-relateddisciplineisrequired. Advanced degree preferred (M.S.,Pharm.D, Ph.D.).
Minimum of5years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance).
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.
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Pay Transparency Nondiscrimination
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.
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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.
No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R145607