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.

Responsible for providing oversight of the day-to-day operational activities of Global Safety Reporting (GSR) and providing support to junior members of staff. The Scientist will also participate in collaborations with internal and external business partners and help to write and update procedural documents, be involved in continuous process improvement, metrics collection and training/mentoring of other staff in GSR. The position will also complete other relevant tasks of special assignments and provide back up to the Manager/Director as required.

Primary responsibilities:

• Ensure accurate and timely electronic and manual submission/transmission of Individual Case Safety Reports to Regulatory Authorities and/or Business Partners, including vendor management and implementation/completion of activities required for oversight of compliance and quality

• Collaborate with the internal and global teams to manage operational activities and resources on an ongoing basis

• Collaborate effectively with internal and external stakeholders (e.g., Business Partners, Global Clinical Operations, Local Safety Officers, Medical Safety Quality Management, Systems, Pharmacovigilance Systems Support)

• Assume a leadership role in driving the creation and continuous improvement of consistent processes that meet both internal and regulatory standards

• Proactively identify, investigate, and resolve/mitigate system and process issues

• Provide support to audits and inspections

• Mentor/supervise junior staff and provide training/coaching to team members

• Participate in Quality Investigations and Corrective and Preventative Action (CAPA) activities

• Perform other functional duties and contribute to projects/initiatives as assigned

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

Qualifications

Education:

• Bachelor's degree required, preferably in a health-related field

Required:

• A minimum of 4-6 years' relevant clinical or pharmaceutical experience

• Expertise in case management and pharmacovigilance operations

• Knowledge of global regulatory requirements and related systems

• Strong problem-solving, communication and influencing skills

• Demonstrates initiative and autonomy in achieving objectives

• Able to work independently and collaboratively with teams

• Ability to produce high quality work under time critical and high-pressure situations

• 10% travel (domestic & international)

Preferred:

• Experience in regulatory reporting/submission

• Project management skills

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

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 29, 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.