Submissions & Regulatory Intelligence Manager (Clinical Data Standards)

Contributes to the Clinical Data Standards team as an individual contributor who is a developing subject matter expert, and who works independently with minimal supervision and who takes a leadership role in the collaboration with various internal and external partners. Consults on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy. Applies in-depth knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area. Ensures consistency of clinical data standards across clinical trials and in compliance with regulatory requirements. 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.
You will be responsible for: The Submissions & 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.
• Acts as a top-level specialist to establish programs and innovative initiatives for the organization to advance Clinical Data Standards initiatives
• Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements.
• Participates in the development of processes to provide accurate, timely, and consistent clinical data standards to study teams.
• Communicates ideas for process improvement, while assisting in developing and implementing new technologies for development and implementation of clinical data standards.
• Coaches and trains junior colleagues in clinical data standards techniques, processes, and responsibilities.
• Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.
  
  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 is required!
• Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM)
• Written and verbal communications skills
• Customer focus and solution-oriented experience
• Interpersonal skills to build relationships with internal and external business partners
• Leadership on cross-functional projects, decision making and problem solving
• Excellent spoken and written English
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s)

J&J Family of Companies Submissions & Regulatory Intelligence Manager (Clinical Data Standards) in High Wycombe, United Kingdom 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

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. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits