Johnson & Johnson Innovative Medicine
Submissions & Regulatory Intelligence Manager
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Submissions & Regulatory Intelligence Manager
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Clinical Data Management
Job Category:
Professional
Job Location:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Role Overview:
We are searching for a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to contribute to the Clinical Data Standards team as an individual contributor and a developing subject matter expert. The role involves taking 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.
Locations:
This role may be located in High Wycombe/Maidenhead, United Kingdom; Beerse, Belgium; Allschwil, Switzerland; Leiden, Netherlands; or Spring House/Raritan/Titusville, United States (Hybrid / 3 days onsite per week preferred).
Purpose:
- 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.
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Responsibilities:
- Provides significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies.
- 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.
- Acquires and maintains deep expertise in current Regulatory Health Authority (RHA) and industry guidance and RHA validation/compliance rules in relation to data submission packages (e.g., SDTM/ADaM submission packages).
- Supports the ownership by SRI of any tools, system, checklists, templates, etc., that facilitate data package compliance checking for IDAR.
- May serve as the lead of the Submission Center of Excellence, responsible for workload distribution amongst the team and working at the trial level post-DBL to ensure SDTM, ADaM, and documentation submission-readiness.
Qualifications / Requirements:
- 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.
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Benefits:
- Competitive salary and extensive benefits package.
- Flexible working environment valuing work-life balance.
- Career development opportunities.
Equal Opportunity:
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. Reasonable accommodations will be provided for individuals with disabilities.
Required Skills:
- Advanced Analytics
- Clinical Data Management
- Clinical Trials Operations
- Data Privacy Standards
- Data Savvy
- Good Clinical Practice (GCP)
- Innovation
- Leverages Information
- Process Improvements
- Regulatory Affairs Management
- Research Ethics
- Technical Credibility
Preferred Skills:
- None specified.
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