Sr. Scientist, Regulatory Affairs

Merck•North Wales, PA

20h•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 Senior Scientist, Global Labeling Lead 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

Requirements

Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance).
Experience in 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.
Ability to assimilate clinical and scientific information, labeling precedent and competitor labeling, and present it concisely. Understanding of medical concepts and terminology.
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.
Adverse Event Report
Clinical Medicine
Compliance Investigations
Decision Making
Detail-Oriented
Disease Prevention
Documentations
Employee Training Programs
Labeling Compliance
Maintenance Processes
Manufacturing Compliance
Multi-Management
Negotiation
Oral Communications
Pharmaceutical Management
Policy Implementation
Proactive Thinking
Records Retention Management
Regulatory CMC
Regulatory Communications
Regulatory Compliance
Regulatory Strategy Development
Regulatory Submissions
Technical Writing

Nice To Haves

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

Responsibilities

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