Job Information
J&J Family of Companies Submission Scientist, Global Safety Reporting in Horsham, Pennsylvania
Submission Scientist, Global Safety Reporting - 2406218016W
Description
Johnson and Johnson is currently seeking a Submission Scientist, Global Safety Reporting located in Horsham, PA or Raritan, NJ.
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.
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:
- Bachelors 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 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
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.
Primary Location NA-US-Pennsylvania-Horsham
Other Locations NA-US-New Jersey-Raritan
Organization Janssen Research & Development, LLC (6084)
Relocation Eligible: No
Job Function Pharmacovigilance
Req ID: 2406218016W
J&J Family of Companies
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