Principal Scientist – Global Labeling Lead

MSD

Principal Scientist leading Global Labeling efforts in pharmaceutical industry. Developing and implementing comprehensive labeling strategies for global compliance.

Posted 6/11/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $173,200 - $272,600 per yearWebsite

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Hard Skills

labeling experienceregulatory requirementslabeling strategyproject managementrisk evaluationlabeling policieslabeling procedureslabeling compliancelabeling documentationclinical and scientific information

Soft Skills

leadershipmentoringactive listeningproblem-solvingcommunicationinterpersonal skillsattention to detailinfluencenegotiationtolerance for ambiguity

Industry Keywords

pharmaceutical industryMedical AffairsRegulatory AffairsClinicalPharmacovigilanceGlobal Regulatorylabeling expertiseaudits/inspectionslabeling precedencecross-functional teams

About the role

Key responsibilities & impact

developing, maintaining, and implementing Core Labeling and target 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, assimilating labeling precedence and competitor labeling, 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 (both direct reports and 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 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 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, coaching, training and may provide management support to other Global Labeling Leads

Requirements

What you’ll need

Minimum of 7 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance)
Skilled and effective at leading and mentoring team members and leading cross-functional labeling teams (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, including labeling precedent and competitor labeling, and present it concisely.
Understanding of medical concepts and terminology and how it applies to regulatory requirements and labeling strategy.
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.
Excellent written and oral communication skills.
Strong interpersonal skills.
Attention to detail and accuracy.
Ability to influence and negotiate.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days