Submissions & Regulatory Intelligence Manager

We are searching for the best talent for a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR), to contributes to the Clinical Data Standards team as an individual contributor and a developing subject matter expert, to take a leadership role in the collaboration with various internal and external partners. The Submissions & Regulatory Intelligence Manager provides expert guidance and implements tailored solutions on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy. Foremost is ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.,

• Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization
• Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements.
• Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams
• Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards.
• Coaches and trains junior colleagues in clinical data standards application and responsibilities.
• Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.
You will be responsible for: The Submissions & Regulatory Intelligence Manager is responsible for providing significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies. Examples of this content are:
• Newly released or updated Regulatory Health Authority (RHA) and industry guidance documentation
• Identification of clinical study data submission information critical to IDAR submission processes and procedures, including providing an interpretation of such information if needed
• IDAR submission requirements and rules
The position serves as the single Point of Contact for any stakeholder on data management, clinical and statistical programming, and global regulatory affairs, for data submission deliverable requirements and makes sure these teams have a very clear understanding of these deliverables, the need for compliance, the difference between RHA requirements and the general submission processes. The Submissons & Regulatory Intelligence Manager is responsible for acquiring and maintaining deep expertise in current RHA and industry guidance and RHA validation/compliance rules in relation to data submission packages (e.g., SDTM/ADaM submission packages). The position supports the ownership by SRI of any tools, system, checklists templates, etc., that facilitate data package compliance checking for IDAR. The position may serve as the lead of the Submission Center of Excellence, serving as POC for study teams requesting SubCOE support, responsible for workload distribution amongst the team, working at the trial level post-DBL to ensure SDTM, ADaM, and documentation submission-readiness.


• A Bachelor's degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD)
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming!
• Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM)
• Experience with regulatory submissions (NDA, BLA) is an asset
• Demonstrated written and verbal communications skills
• Demonstrated customer focus and solution-oriented experience
• Demonstrated interpersonal skills to build relationships with internal and external business partners
• Demonstrated leadership on cross-functional projects
• Demonstrated leadership in decision making and problem solving
• Excellent spoken and written English
  
  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 jnj.com (https://www.jnj.com.) .
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation.