Johnson & Johnson Careers
Lead Clinical Operations Safety Specialist
Titusville, New Jersey
Clinical Trial Administration
Requisition ID: 0214181219
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Lead Clinical Operations Safety Specialist, for our site in Titusville, NJ.
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Lead Reporting Specialist will work closely with safety reporting team ensuring that Outbound Safety Reporting of SUSARs to Investigators/IECs/IRBs is carried out within agreed timelines and in line with all the applicable SOPs and compliance and regulatory standards.
The Lead Safety Reporting Specialist will lead and participate in projects and initiatives related to outbound safety reporting, in audits/inspections and will act as key contact delegate in business partner discussions.
The Lead Safety Reporting Specialist may act as the business owner for assigned processes and/or systems and/or support continuous.
- SUSAR search and retrieval from Global Medical Organization (GMO) database.
- Retrieval of DSURs and SUSAR LLs from Regulatory Submissions Management & Operations / other safety partners.
- SUSAR/SUSAR LL/DSUR case distribution via safety reporting systems according to the GCO SU's current processes.
- Effectively partner with business partners across GCDO and GMS in support of safety reporting or other related activities.
- Business and/or System Owner for safety reporting system.
- Provide system support for safety reporting systems including: UAT test and system validation testing as need, document updates for systems, training and support to other team members as needed.
- Liaise with vendors or other outside parties on behalf of the team.
- Support and lead projects as needed.
- Develop or update departmental documentation as needed.
- Ensure compliance with internal procedures, regulatory standards, and partner agreements to ensure inspection readiness at all times. Represent GCO SU as apart of audits and inspections as needed.
- Mentor, train and support other members of the team as required.
- Bachelor’s degree in a science or healthcare related discipline or equivalent is required.
- Minimum of 6 or more years pharmacovigilance experience or other equivalent clinical operations or pharmaceutical experience is required.
- Understanding of Intralinks or other SUSAR distribution system is preferred.
- Working knowledge of FDA and international pharmacovigilance and clinical safety regulations and guidelines is required.
- Detailed understanding of safety reporting processes within clinical trials is preferred.
- Excellent written and verbal communication skills is required.
- Ability to communicate complex issues to internal and external partners driving effective decision-making is required.
- Ability to prioritize multiple important tasks and maintain high quality of work and appropriately communicate items that could impact timelines or quality is required.
- Detail oriented collaborator with demonstrated ability to adapt to change is required. Proven experience in a multi-disciplinary environment is required.
- Cross-functional Coordination Skills – ability to collaborate within own department/function as well as across departments to resolve issues is required.
- Problem Solving / Decision-making – takes an active role in analyzing and synthesizing problems and issues is required.
- Risk Management Skills – evaluates risks based on sound business analyses is preferred.
- Project Management – ability to take a leadership role in managing projects is preferred.
- Demonstrated use of continuous improvement methodology such as lean, six sigma etc. is preferred.
- Quality Management skills – quality management activities (ex. inspection readiness) is required.
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Janssen Research & Development, LLC. (6084)
Clinical Trial Administration