RA PROFESSIONAL ERMC EUCP LABELING (1-YEAR CONTRACT)

Johnson & Johnson is recruiting for an ERMC EUCP Labeling RA Professional to be based in our office in Beerse, Belgium.
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.
nj.
om/.
The key responsibility of the ERMC EUCP Labeling RA Professional is to coordinate labeling translations, linguistic review and submission of EU Product Information (EUPI) according to Health Authority and JnJ requirements.
Are you interested to work with us in an international and multi-cultural team? If you like to look beyond your own country, then this position might interest you! Job description We are looking for a Regulatory Affairs professional to join the EMEA Regulatory Management Centre, a virtual team of enthusiastic, international colleagues.
This position is in the EUCP Labeling Excellence team where the focus is primarily on the centralized approved products.
You will work closely together with both regional and local colleagues to ensure high quality and timely submissions to the Health Authorities.
Key Responsibilities.
Obtaining the information from the EMEA TA on the upcoming EU procedures resulting in EUPI modifications Co-ordination of translation activities of English source document in collaboration with translation vendor (central or local), ERMC team and LOCs.
Ensuring the accuracy of the translated Product Information Annexes of Marketing Authorization against the reference English document in compliance with EU, reference country and /or local legislations.
Performing and/or co-ordination of Quality Check (QC) of local PI in cooperation with external vendor and LOCs.
Maintaining the compliance of local translated EU PIs in the Company validated repository system.
Communicate efficiently with other ERMC sub-teams, LOCs and EMEA TA in scope throughout the process.
Support in maintaining marketing authorizations.
Qualifications Education University degree Experience and skills.
Required.
Good organizational and communication skills Proficiency in written and oral English Proficient in MS Office suite Task prioritisation skills QRD convention knowledge Preferred.
Knowledge of Company's systems and tools Working knowledge of tools used for Quality control and translation processes (e.
.
TVT, Adobe, RIMdocs, etc) Ability to interpret EU regulation as they apply to submissions in the countries in scope Experience in a global organization Other.
The position is based in Belgium.
No relocation is offered.
It is a time-limited contract of one year.
Candidate has to be able to work flexible hours to accommodate early morning/evening meetings/teleconferences with different time zones.
Occasional international travel (~2x per year) may be required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.