Johnson & Johnson Careers

EMEA RMC Regulatory and Data Management Compliance Coordinator

undefined, Central Serbia
Regulatory Compliance


Job Description

Requisition ID: 1805647701W

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.

Janssen, part of Johnson & Johnson Family of Companies is now looking for Regulatory and Data Management Compliance Coordinator:

 

Regulatory and Data Management Compliance Coordinator

Located in Serbia

Full-time contract 

 

As Regulatory and Data Management Compliance Coordinator, you will have the following areas of responsibility

  • Contribute to improvement of the compliance and data integrity in close cooperation with the ERMC Data Management Specialists,
  • Participate in performing ERMC-internal gap analysis,
  • Support the ERMC Planning Lead in the tracking of RMC activities,
  • Collaborate with process stake holders like ERMC Data Management Specialists, database teams and Regulatory Affairs stake holders to improve efficiencies of the planning and tracking systems,
  • Collect and document solutions of specific Regulatory Affairs processes in the given IT environments in closed cooperation with the ERMC Database Specialists
  • Act as backup solution for Data Management Specialists in urgent cases to ensure compliance
  • Support appropriate training assignments for ERMC team members

Qualifications

Qualifications and experience of the successful candidate:

  • A minimum of a University degree in biosciences or equivalent by RA /Quality experience
  • At least 7 years of regulatory experience
  • The following experience would be an asset: in people leading, in a virtual team and/or local affiliate organization would be of advantage
  • In depth knowledge of local and regional regulations/legislation
  • Experience in working with limited supervision and able to make independent decisions
  • Excellent verbal and written communication skills
  • Proficiency in written and oral English
  • Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
  • Proactive team player, able to take charge and follow through. 
  • Achievement - oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
  • Proficient use of technology including RA tracking systems - preferred

Primary Location
Serbia-Central Serbia-
Organization
Johnson & Johnson d.o.o. Ogranak u Beogradu (8392).
Job Function
Regulatory Compliance
Requisition ID
1805647701W