Submission Scientist, Global Safety Reporting

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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 world's 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/coachin...