RA Professional Labeling EMEA (1-year contract)

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

About Johnson & Johnson

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 where 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/.

Johnson & Johnson is recruiting for an RA Professional Labeling EMEA in Warsaw, Poland. This is a temporary contract with Johnson & Johnson for the duration of 1 year.

Key Responsibilities:

Co-ordinating of translation activities of English source text (e.g. EU Product Information (EUPI)) in cooperation with external vendor (central or local), applicable C-ROSS teams and LOCs.

• Performing and/or co-ordinating the Quality Check (QC) of labeling documents – in cooperation with external vendor/translator, LOCs and Medical Affairs as applicable.
• Maintaining the compliance of labeling documents in the Company validated repository system.
• Effectively communicate with applicable internal and external stakeholders (i.e. C-ROSS sub-teams, LOCs and EMEA TA) throughout the process.
• Ensuring implementation of standardization/new systems and processes to ensure efficiency gains and to support business continuity.
• Developing/Customizing text for MEWA labeling documents based on reference country English source text (e.g. EU Product Information (EUPI)) and local HA requirements.
• Involvement in other tasks and/or projects based on business needs as assigned.

Qualifications

• A Bachelor's degree in a scientific or equivalent field or a Master’s degree is preferred.
• Good understanding of the pharmaceutical industry; regulatory experience in drug development and/or maintenance of marketed products
• Detailed knowledge of local regulations and guidance s in the cluster/region related to the full drug life cycle; understanding of how these apply to specific projects and how to interpret them in the context of the scientific and commercial environment
• Expert in detailed labeling work, with a specialized focus on regional and global submission requirements
• Ability to quickly acquire country-specific knowledge and shift between different local situations
• Experience in working in a multi-cultural virtual environment

Preferred:

• Knowledge of quality and supply chain and potential impact on regulatory procedures and status of products
• Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products

Other:

• Ability to communicate fluently in English (including business and RA technical English)
• Intercultural sensitivity to enable smooth collaboration with colleagues across EMEA
• Identify and act on process optimization opportunities.
• Defines operational priorities and tactics.
• Resolves conflict in alignment with the line manager.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

The anticipated base pay range for this position is 95.000 PLN to 152.000 PLN annually.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

 

 

Required Skills:

 

 

Preferred Skills: