Senior Specialist, Process & Data Management (PDM) Systems Expert

Senior Specialist, Process & Data Management (PDM) Systems Expert – 2406216762W

Description

Johnson & Johnson is recruiting for a Senior Specialist, Process & Data Management (PDM) Systems Expert , to be located in Horsham, Pennsylvania . Alternative locations include Titusville, Pennsylvania; Beerse, Belgium and High Wycombe, England.

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/.

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 worlds most pressing healthcare challenges. 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. At Johnson & Johnson, we all belong.

The Sr. Specialist, PDM Systems Expert supports development and maintenance of standard processes for the systems used within PDM. Duties include analyzing system usage data, system maintenance and reporting, data management and governance activities, assisting colleagues in performing data-related tasks, and providing technical support to users by identifying, investigating, and resolving problems.

Key Responsibilities:

R&D Quality is responsible for Quality and Compliance Oversight and related Risk Management for the Research and Development organization. In that perspective, R&D Quality is intensively collaborating with key partners including the Therapeutic Areas, Global Development, Global Regulatory Affairs, and the Global Medical Organization along the development process, from discovery, pre-clinical, clinical, launch to post-approval activities. The Process and Data Management team is responsible for providing compliant, easily accessible process content, and for making learning tailored to the moment-of-need and at the point-of-use.

As Sr. Specialist, PDM Systems Expert, you develop and maintain standard processes for the systems owned and used within PDM. You support the development, setting and maintenance of the standards-of-use for these systems, and in that way, synchronize the system processes with the needs of the users and customers to ensure optimal use of the systems. You support the resolution of issues and deficiencies related to the systems within your portfolio. The incumbent supports the management of the system processes end-to-end, including system change management, system data and meta-data structuring and management, as well as supporting audits and inspections as a point of content for the system functionality and reporting.

You develop and maintain system standards in the current as well as in the targeted system landscape, and support automation and digitalization projects. You analyze the performance data from the processes ran through the systems and seek to continuously improve the standard processes while reducing hands-on time and decreasing cycle times.

You ensure timely system-related process reporting for the PDM and the R&D Quality organization and assist the organization in identifying and resolving prioritization and resource issues while ensuring within-target performance.

You maintain supporting departmental tools, such as glossaries, tables, and master data libraries. You work closely within the PDM department to support key projects and programs aimed to digitalize and automate processes. You support (Quality) System administration, archiving and reporting in line with departmental and procedural requirements.

Qualifications

Education:

University/Bachelors or equivalent degree in Science, Business or relevant field is required.

Experience and Skills

Required:

A minimum of four to six (4-6) years of related work experience.

Experience in a medium-to-large-scale, matrixed Life Sciences organization.

The ability to communicate well, both in oral and written form (in English) and using a variety of media.

Demonstrated competencies include industriousness, self-awareness, adaptability, attention to detail and a high capacity for collaboration.

Experience with various aspects of Data Management including but not limited to data cleaning, monitoring, reporting, governance, and lifecycle management.

Experience ensuring the accuracy and quality of collected data, and the integrity of the data being worked with.

Partnering with stakeholders to analyze data and generate insights.

Good knowledge of worldwide clinical and preclinical safety compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry, specifically regarding GxP and non-GxP System expectations.

Preferred:

Strong networking and relationship building skills.

Ability to create an open and inviting environment.

Ability to embrace generational differences.

Understanding of the digital and data science landscape.

Strong written and verbal communication skills.

Analytical approach with problem-solving skills.

Proficiency with MS Office products (Word, Excel, PowerPoint, Outlook).

Proficiency with Project Management software (e.g., Wrike).

Knowledge of System Development Lifecycle Management (SDLC), business process modeling software and automated workflow tools.

Other:

The anticipated base pay range for this position is $90,000 to $144,900.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys 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 of Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below. 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.

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-Pennsylvania-Horsham

Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-US-New Jersey-Titusville

Organization Janssen Research & Development, LLC (6084)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function Quality Documentation

Req ID: 2406216762W