Global Submissions & Regulatory Intelligence Lead

Johnson & Johnson Innovative Medicine; Allschwil; Hybrid; CHF 117,000 - 202,000; Full time

Benefits offered by this job

Competitive salary

Flexible working environment

Career development opportunities

Job summary

Johnson & Johnson Innovative Medicine in Basel-Allschwil, Switzerland, seeks a Submissions & Regulatory Intelligence Manager to lead Clinical Data Standards within IDAR, ensuring SDTM/ADaM compliance and regulatory submission readiness across programs.

The role requires a science degree, 6+ years in pharma, and excellent English, with international location options and a strong focus on data quality, standards programs, and mentoring of junior staff.

Qualifications

• Bachelor's degree in a scientific, technology or healthcare discipline or equivalent experience.
• At least 6 years of relevant pharma/scientific experience in a related discipline (data management, biostatistics, clinical or statistical programming).
• Expert knowledge of relevant regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Experience with regulatory submissions (NDA, BLA) is an asset.

Responsibilities

• Acts as a top-level specialist to establish programs and innovative strategies for Clinical Data Standards.
• Manages standards, projects, programs, or processes for Clinical Data Standards in line with internal strategy and regulatory requirements.
• Participates in developing solutions to provide accurate, timely, and consistent clinical data standards to study teams.
• Coaches and trains junior colleagues in clinical data standards application and responsibilities.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

Good Clinical Practice

Innovation

Leadership

Process Improvements

Regulatory Affairs Management

Research Ethics

Technical Credibility

Education

Bachelor's degree in a scientific, technology or healthcare discipline

Advanced degrees preferred (e.g., Master, PhD)

Job description

Johnson & Johnson Innovative Medicine in Basel-Allschwil, Switzerland, seeks a Submissions & Regulatory Intelligence Manager to lead Clinical Data Standards within IDAR, ensuring SDTM/ADaM compliance and regulatory submission readiness across programs.

The role requires a science degree, 6+ years in pharma, and excellent English, with international location options and a strong focus on data quality, standards programs, and mentoring of junior staff.