Submissions & Regulatory Intelligence Manager (Clinical Data Standards)

Location: High Wycombe/Maidenhead, United Kingdom; Beerse, Belgium; Allschwil, Switzerland; Leiden, Netherlands; or Spring House/Raritan/Titusville, United States. Hybrid work with 3 days onsite per week preferred.

Salary: $117,000–$201,250 USD annually, plus eligibility for an annual performance bonus.

Company

Johnson & Johnson develops healthcare, innovative medicine, and MedTech solutions focused on preventing, treating, and curing complex diseases.

What you will do

• Establish programs and strategies that advance the Clinical Data Standards organization.
• Provide expertise on clinical study data regulatory submission requirements, health authority guidance, and industry standards.
• Act as the point of contact for data management, clinical and statistical programming, and global regulatory affairs stakeholders.
• Maintain submission compliance tools, systems, checklists, templates, and validation requirements for SDTM and ADaM data packages.
• Lead or support the Submission Center of Excellence, including workload distribution and trial-level submission readiness after database lock.
• Coach junior colleagues and contribute to process improvements and technology integration.

Requirements

• Bachelor’s degree in a scientific, technology, or healthcare discipline, or equivalent experience; advanced degrees are preferred.
• At least 6 years of relevant pharmaceutical or scientific experience in data management, biostatistics, clinical programming, or statistical programming.
• Expert knowledge of regulatory requirements such as GCP and ICH, and industry standards including SDTM and ADaM.
• Experience with regulatory submissions such as NDA or BLA is an asset.
• Demonstrated communication, interpersonal, leadership, decision-making, problem-solving, and customer-focused skills.
• Excellent spoken and written English required.

Culture & Benefits

• Inclusive work environment guided by Johnson & Johnson’s Credo and Leadership Imperatives.
• Medical, dental, vision, life insurance, disability, business accident, and group legal insurance for eligible employees and dependents.
• Retirement pension and 401(k) savings plans for eligible employees.
• Paid vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and personal and family time.
• Eligibility for long-term incentive and annual performance bonus programs.