Principal Scientist (Director) - Global Labeling Lead

MSD•North Wales, PA

4d•$173,200 - $272,600•Hybrid

About The Position

We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling 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. As part of Labeling Strategy function in Global Labeling, you will be accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) , US Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country’s Local Labeling. The Principal Scientist, Global Labeling Lead is responsible for: - 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

Bachelor’s degree in a scientific or medically-related discipline
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 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, 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
Adaptability
Clinical Judgment
Data Quality Assurance
Detail-Oriented
Innovation
Policy Implementation
Publications Management
Records Retention Management
Regulatory Compliance Audits
Regulatory Submissions
Regulatory Training
Team Collaboration
Technical Documentation Management
Technical Writing
Training and Development

Nice To Haves

Advanced degree (M.S., Pharm.D, Ph.D.)

Responsibilities

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
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