Global Labeling Sr Scientist – Regulatory Affairs Full-time

Global Labeling Lead

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join us in our mission to use the power of leading-edge science to save and improve lives around the world.

We invite you to join our mission of advancing the prevention and treatment of diseases. In the capacity of a Global Labeling Lead, you will be instrumental in shaping the labeling strategy and ensuring the development of compliant, high-quality labeling documents to facilitate the safe and effective use of our products worldwide.

This role provides opportunities for professional growth, strategic planning, and allows you to demonstrate your superior execution skills.

Core Responsibilities:

• As a Global Labeling Lead, you will guide cross-functional teams in the creation, review, and approval of Core and Local Labeling documents.
• You will facilitate Labeling Committees comprised of senior level cross-functional stakeholders and work closely with data owners and subject matter experts regarding scientific and medical information.
• You will be responsible for the development and maintenance of Core and US Labeling for assigned products, ensuring compliance with internal and regulatory standards.
• You will assist in the development and maintenance of Local Labeling for EU and other countries.
• You will propose strategies and labeling language during development or in response to Health Authorities.
• You will serve as a subject matter expert, providing advice and guidance on labeling to teams, including labeling precedence and competitor labeling.

Qualifications:

• Physician, or Master’s degree in nursing (BSN), pharmacy, Physician’s Assistant, or other relevant clinical health related field.
• Minimum of 4 years of pharmaceutical label writing experience or relevant regulated industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance, Medical Writing).
• Excellent writing and oral communication skills in English.
• Proficient project management skills with the ability to handle multiple tasks and prioritize effectively.
• Ability to perform well in ambiguous situations.
• Proactive and action-oriented approach.
• Attention to detail and focus on accuracy.
• Skills in influencing and negotiating.
• Ability to break down complex scientific & medical issues and propose solutions.
• Effective at leading cross-functional teams with senior leader participation and to drive productive discussions aimed to build alignment on scientific and medical content for assigned products.

Required Skills: Accountability, Action-Oriented, Adverse Event Report, Compliance Investigations, Detail-Oriented, Documentations, Employee Training Programs, Labeling Compliance, Negotiation, Policy Implementation, Records Retention Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

Preferred Skills: