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 Senior Intake Operations Scientist supervises the operational and management activities of identified case receipt staff to ensure compliance with worldwide safety regulations and corporate policies. Monitoring of daily workload activities to maintain regulatory compliance and quality standards. Oversight of external partners/vendors contracted to perform Case Receipt activities, supports inspections/audits and point of contact for training activities. Act as a key contact or point of expertise for the department and external contacts for designated products or processes.

Liaises with staff in Global Medical Safety Operations (GMSO) functions (e.g. Global Case Management (GCM), Global Case Processing, Global Safety Reporting, Global Clinical Operations, Call Centers, Local Safety Officers) and internal/external partners/vendors contracted to perform Global Case Receipt activities as appropriate to facilitate compliant, timely and efficient end-to-end case management.

Primary responsibilities:

• Partner with internal and external stakeholders for accurate and timely intake of ICSRs

• Facilitate workload meetings to ensure resource distribution aligns with evolving business needs

• Support initiatives to enhance system capabilities and contribute to process development

• Monitor workload to meet product-specific reporting obligations and manage corrective/preventative actions

• Participate in PVA Implementation and Vendor Touch Point Meetings; collaborate with Compliance Strategy and Analytics for late case requests

• Strategically plan resources to manage fluctuating activities and escalate needs when necessary

• Oversee the telephone follow-up program for ICSRs in compliance with regulations and company policies

• Participate in audits, inspections, and project work, including process improvements and CAPA activities

• Monitor operational performance and develop strategies for efficiency in case receipt activities

• Mentor and supervise Case Receipt staff, participate in recruitment, assist in onboarding new hires, and manage performance evaluations and development plans as applicable

• Lead the Global Case Receipt staff and direct operational activities, including vendor management

• Ensure awareness and adherence to company procedures and complete required training

Qualifications

Education:

• Bachelor's degree required, preferably in the Health/Biomedical/Data Analytics field

Required:

• 5+ years Pharmaceutical experience

• Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports and safety systems.

• Extensive knowledge and experience with single case management and regulatory compliance

• Ability to analyze complex situations, evaluate information and evidence, and make informed decisions to improve efficiency, accuracy and compliance.

• Demonstrates initiative and autonomy in achieving objectives.

• Able to see the broader perspective and anticipate the consequences of business decisions.

• Possesses knowledge of global regulatory pharmacovigilance requirements.

• Skilled in prioritizing, planning, and organizing work within strict timelines.

• Able to work independently and collaboratively with teams.

• Potential to travel up to 10% (Domestic & International)

Preferred:

• Experience collaborating with vendor partners

• Experience with Visio and Excel

The anticipated base pay range for this position in the US is $105,000 to $169,050.

The anticipated base pay range for this position in San Francisco Bay Area is $121,000 to $194,350.

* 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.

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

This job posting is anticipated to close on October 28, 2024. 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.