Associate Systems and Processes, Cmc Regulatory
il y a 2 semaines
Janssen 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.
**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
**Qualifications**:
**Position 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)).
**Emp
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