Manager, RA Labeling Product Leader

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Warsaw, Masovian, Poland

Job Description:

Key Responsibilities:



* Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI), and derived documents (labeling text for EU, US) for assigned compounds.


* Make recommendations and provides advice and guidance about labeling content, processes, timelines, and scientific integrity.

Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation.

Ensure high quality and compliant labeling documents.

This role may collaborate with external partners.


* Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.


* Contribute to the continuous improvement of the end-to-end labeling process.

Qualifications

Education


* A minimum of Bachelor’s degree (or equivalent) (required)


* A degree in a scientific discipline (required)


* An advanced degree (MS, PhD, MD or PharmD) (preferred)

Required Skills:



* Minimum of 4 years professional experience


* Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 3 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent


* An understanding of pharmaceutical drug development


* Experience in discussing and communicating scientific concepts


* Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling


* Experience leading project teams within a matrix environment, combined with the ability to work independently


* A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, organizational negotiation and partnering skills


* Experience working in document management systems

Preferred Skills:



* Ability to manag...