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Associate Systems and Processes, CMC Regulatory Affairs - 2406161573WDescriptionJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Regulatory Affairs - CMC. The preferred locations for this role are Beerse, Belgium, and Titusville, NJ. This role is primarily on-site with hybrid possibilities.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.Principal responsibilities
Assist in driving operational efficiencies and effectiveness for Global CMC Regulatory Affairs (CMC RA) that optimizes the department’s capabilities and improves overall quality, efficiency, and productivity by ensuring systems are fit for purpose and used optimally
Serves as a base-level technical SME on internal teams to provide input for internal and external system development activities including user requirements, reporting requirements, data field definition, system-to-system interaction, business systems architecture, and landscape
Provides base business-level technical support and training for systems as well as data migration and integrity initiatives as systems are updated or changed
Performs and manages data entry activities to support department systems. Performs System administrator role for metadata maintenance.
Assists with accurately organizing and maintaining department data by developing of process flow, job aids training, and ensuring data entry follows appropriate guidelines
Assists the System and Process owner for internal or external systems
Helps with the planning and organizing of activities across CMC RA and the wider organization.
May participate in selected initiatives within the team
Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements, and expectations.
Communicates major flaws to Management
May represent CMC RA on Multi-functional Teams
Sphere of Authority
Assists with the coordination and integration with other CMC RA Technology groups/initiatives to ensure the needs are addressed and issues raised as needed
Works to make efficient business processes and drive continuous improvement of working practices to increase the efficiency of the CMC RA team. Calls out critical issues to CMC RA management
Delivers training for the use of departmental IT systems
Communicates considerately and efficiently within CMC RA and GRA; maintains good rapport and credibility
QualificationsPosition Requirements
BS in biological, pharmaceutical, chemical, or engineering sciences with preferably some years of experience, including post-graduate education and/or pharmaceutical or healthcare industry experience or equivalent. An MS preferred
Solid grasp of biology, chemistry and/or engineering relevant to the pharmaceutical industry
Proven attention to detail with high-level verbal and written communication skills, high accuracy levels
Strong Systems skills and comfortable with all types of information technology
Communicates cross-functionally and cross-company
Demonstrates model behavior that understands what the priorities are and encourages others to work towards results
Good knowledge of global HA laws, regulations, guidelines, and submission routes available.
Experience with regulatory submissions, processes, and systems
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.The anticipated base pay range for this position in the San Francisco Bay Area, CA is $81,000 to $129,605.The anticipated base pay range for this position in all other US locations is $70,000 to $112,700.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 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
Additional information can be found through the link below.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.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please get in touch with us to request accommodation.Primary Location Europe/Middle East/Africa-Belgium-Antwerp-BeerseOther Locations NA-US-New Jersey-TitusvilleOrganization Janssen Pharmaceutica N.V. (7555)Job Function Regulatory AffairsReq ID: 2406161573W
Vacancy caducado!