Job Information
J&J Family of Companies IDMP DATA TECHNOLOGY LEAD in Raleigh, North Carolina
IDMP DATA TECHNOLOGY LEAD - 2206084449W
Description
Johnson & Johnson Consumer Health is recruiting for a data, technology and business process lead for its IDMP (Identification of Medicinal Products) program and related product data initiatives in Skillman, NJ, High Wycombe, UK or Remote!
Johnson & Johnson New Planned Consumer Health Company, based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
The Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
The data and technology lead works with the IDMP team and other teams to ensure data is digitized and transformed, aligned with external regulatory standards and internal initiatives to deliver connected data across functions. The data and technology lead provides recommendations on methodology solutions for data governance and works with internal and external technology partners to develop a data platform meeting user needs and regulatory submission requirements. As we become increasingly data centric, this role has the potential for future development and growth.
Key Responsibilities :
Lead the data governance plan for IDMP in collaboration with the wider global regulatory CMC and strategic compliance team and data management process.
Follow and interpret existing and upcoming EMA guidance for IDMP and SPOR and translate to practice for J&J Consumer Health medicinal portfolio in Europe and potentially for other regions as IDMP becomes more widely adopted.
Be the technical guide and advisor for the program for IDMP preparation and implementation.
Partner with external vendors and wider team to develop a migration plan for non-digitized IDMP data.
Coordinate with vendor to develop business processes and workflows needed for IDMP data submissions and related regulatory processes.
Work with partners to develop a process for IDMP data governance, aligned with the wider organization goals.
Develop process flows and work instructions for IDMP data governance.
Coordinate with IDMP team lead and IDMP Regulatory lead to pilot IDMP data submissions and governance and implement in line with EMA guidance.
Support the development of an industry wide data model for non-medicinal consumer products working with internal and external industry partners.
Effectively communicate proposals to partners and senior leadership.
Qualifications
Education:
- Bachelor's Degree or master’s degree in engineering, data science, science or similar subject is desirable.
Experience and Skills:
Required:
5 years of data governance in pharmaceutical industry digital Regulatory Information management, preferably working with European medicines regulatory process.
Hands on experience with implementation of XEVMPD data submissions with EMA desirable.
Experience with consumer product data governance and regulatory labelling desirable.
Document and records management (document based and digital) experience desirable.
Experience and knowledge of working with databases, MS excel, SharePoint, data analytics.
Master data management, data model development experience desirable.
Skills and Competencies required:
Proactive and results oriented.
Ability to work in a decentralized and geographically dispersed team and lead your own area of responsibility.
Ability to work across different teams including Regulatory, R&D, Supply Chain and with external partners.
Good social skills and ability to convey information succinctly both to team and senior leaders.
Track record and demonstrable ability to translate standards and regulatory guidance into effective solutions for an organization.
The anticipated base pay range for this position is $88,000 to $142,025.
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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through pioneering programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.
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.careers.jnj.com.
Primary Location NA-US-New Jersey-Skillman
Other Locations North America, Europe/Middle East/Africa, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization Johnson & Johnson Consumer Services EAME Ltd.
Job Function Regulatory Compliance
Req ID: 2206084449W
J&J Family of Companies
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