Senior Manager, Global Regulatory Affairs Data Management

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 Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Global Regulatory Affairs (GRA) Data Management. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.

As the Senior Manager, GRA Data Management, you will be responsible for leading our GRA data dictionary, lineage, and cataloging activities. This role will involve data standardization, data quality rule authoring, documentation of technical specifications, and other tasks related to creating a strong foundation of data governance and quality improvement practices for GRA. This individual will also develop and analyze data maturity and user satisfaction metrics for our data products in GRA.

Principal Responsibilities: ? Develop and maintain regulatory data lineage and catalogs across multiple platforms and technologies in partnership with data stewards and data owners. ? Assist in creation of data dictionaries to improve organizational data integrity and facilitate user access to data. ? Support reference data standardization activities. ? Support the development of software programs, algorithms, and automated processes that cleanse, integrate, and evaluate large data sets from multiple disparate sources. ? Document Data Quality Rules (DQRs) to facilitate Data Quality Incident (DQI) reporting. ? Coordinate documentation on enterprise data models, data dictionaries, physical database configuration, and daily database maintenance functions. ? Ensure the proper definition, control, and coordination of data elements and standards. ? Ensure appropriate access to data within the enterprise database. Consults with users to determine the need for, use of, and specifications of data requests from the system. ? Perform daily monitoring of database systems and applications. ? Contribute to data product development activities. ? Develop and monitor metrics for user satisfaction of data products.

Qualifications: ? A minimum of a Bachelor?s degree in a scientific, business or technical discipline is required. Master?s degree is preferred. ? A minimum of 8 years of experience in the pharmaceutical or related healthcare industry is required. ? A minimum of 5 years of experience with data management is required. ? Experience in managing data projects or initiatives, including proof of concepts (POCs), from inception to completion is required.Strong understanding of data management practices (data governance, stewardship, ownership, quality) is required. ? Experience with implementing data standards and creation of data quality rules preferred. ? Willingness to stay current with industry trends and emerging technologies is required. ? Experience working in a global, matrixed organization is required. ? Must have excellent verbal and written communication skills. ? Must have strong problem-solving skills with a focus on improving data quality and integrity for investment decisioning. ? The ability to work across various pharmaceutical data sets is required. ? The ability to collaborate with all levels and influence cross-functional teams to make decisions and align on data management practices (GRA, Supply Chain, Quality, Commercial, Clinical, etc.) is required. ? This position will require up to 10% travel.

The anticipated base pay range for this position in all other U.S. locations is $137,000 to $237,750.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation?s performance over a calendar/ performance year. Bonuses are awarded at the Company?s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company?s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:
? Vacation - up to 120 hours per calendar year
? Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
? Holiday pay, including Floating Holidays - up to 13 days per calendar year
? Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on April 3, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

#LI-Hybrid

The anticipated base pay range for this position is :
The anticipated base pay range for this position in all other U.S. locations is $137,000 to $237,750.

Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation?s performance over a calendar/performance year. Bonuses are awarded at the Company?s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company?s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company?s long-term incentive program. Employees are eligible for the following time off benefits: Vacation ? up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington ? up to 56 hours per calendar year Holiday pay, including Floating Holidays ? up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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