Exp RA Professional Data Integrity

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Mexico City, Mexico

Job Description:

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

Coordinate, enter and maintain accurate and timely marketing authorization related data in the assigned systems (primarily InSight, Lift) on behalf of data owners.

• Regulatory Affairs data entry activities
• Track incoming data entry requests and follow up until completion in alignment with global and regional data quality standards and procedures
• Enter data in the relevant systems based on information provided by data owners
• Scrutinize provided data with data owners and instruct data owners as needed, to ensure consistency and quality of data in the relevant systems
• Ensure data owner alignment with data entered in the relevant systems on their behalf
• Coordination and oversight of Regulatory Affairs data entry in LATAM
• Monitor data entry using available tracking tools and address any gaps, delays or non-conformances in line with company processes
• Contribute to resolution of any quality investigations, data gaps, audit and inspection requests
• Align with supervisor and team members to ensure data entry backup capabilities during vacation and holiday periods
• Ad hoc activities
• Support data entry professionals and data owners with guidance, training, instructions on the process and requirements for maintaining data in the relevant systems
• Provide ad hoc reports and data upon request, e.g. in relation to audits, inspections, quality investigations
• Coordinate and/or perform other data management activities upon request, e.g.
• Data verification with data owners
• Data monitoring and follow up with data owners
• Data analysis and data cleansing
• Contribute to process development and process improvement activities in LATAM and globally as needed
• Perform other related tasks as assigned by supervisor
• Maintain compliance with all company policies and procedures.

Minimum Qualification

• Good understanding of pharmaceutical Marketing Authorization data and regulatory procedures
• Understanding of regulatory data planning and tracking requirements
• Knowledge of compliance requirements and advanced process thinking
• Good technical skills and computer proficiency
• Proven ability to monitor multiple actions and timelines and follow up until timely completion
• Ability to work effectively in a matrix organization with multiple cross-functional stakeholders on global, regional and local level
• Excellent cross-cultural communication skills in English
• Flexibility and proactivity
• Team-player

 Other requirements

• Based in a LATAM site
• Reachable during LATAM office hours and outside office hours in case of emergencies
• Flexibility for limited travel (≤5%)

Note: An internal pre-identified candidate for consideration has been identified. However, all applications will be considered

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.  ​

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We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.  ​

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At Johnson & Johnson, we all belong. 

Required Skills:

Preferred Skills:

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented

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