Sr. Scientist-Global Labeling Lead

Merck•North Wales, PA

1d•$106,200 - $167,200•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.

Requirements

Minimum of 3 years of labeling experience or other relevant pharmaceutical industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, or Pharmacovigilance). An advanced degree with relevant labeling or pharmaceutical industry experience gained during graduate studies may be considered equivalent to the experience requirement.
Experience leading cross-functional labeling teams, including interactions with senior management, strongly preferred. Demonstrated ability to actively listen, address labeling issues, develop action plans, build consensus, and drive projects to completion.
Ability to assimilate complex clinical and scientific information, labeling precedents, and competitor labeling, and communicate findings clearly and concisely.
Understanding of medical concepts and terminology.
Project management skills with the ability to manage multiple priorities and meet deadlines.
Proactive problem-solving skills with the ability to make sound recommendations and decisions.
Ability to work effectively in ambiguous environments and maintain an action-oriented approach.
Strong written and verbal communication skills.
High attention to detail and commitment to accuracy.
Demonstrated ability to influence, negotiate, and collaborate across functions.
Action-Oriented
Adaptability
Adverse Event Report
Communication
Detail-Oriented
Labeling Compliance
Negotiation
Pharmaceutical Product Development
Policy Implementation
Problem Solving
Regulatory Strategy Development
Regulatory Submissions
Scientific Knowledge
Technical Writing
Time Prioritization

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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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