Manager, Standards Management (DAS/TFL)

Johnson & Johnson seeks a Manager for Standards Management within the Integrated Data Analytics & Reporting team in Allschwil, CH. This hybrid role focuses on clinical data standards strategy and regulatory compliance.

Positioned within the Integrated Data Analytics & Reporting (IDAR) division, this position serves as a senior specialist dedicated to shaping and executing the Clinical Data Standards strategy. The incumbent provides high-level guidance on programs and processes, driving innovative approaches to advance the organization's standards framework.

Responsibilities

• Oversee standards, projects, and processes for Clinical Data Standards, ensuring alignment with internal strategy and regulatory mandates.
• Collaborate on creating solutions that deliver accurate, timely, and consistent clinical data standards to study teams.
• Propose process improvements and assist in designing and integrating new technologies to enhance clinical data standards.
• Mentor and train junior staff on the application and responsibilities of clinical data standards.
• Create and maintain clear specifications for standard content throughout the data lifecycle, including collection, delivery, analysis, and reporting.
• Build and sustain deep expertise in data collection and analysis tools and templates used in clinical trials.
• Stay informed about industry standards development, trends, and regulatory requirements to support the development strategy.
• Provide operational expertise in cross-functional initiatives.

Requirements

• Bachelor’s degree in a scientific, technology, or healthcare discipline, or equivalent experience.
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline.
• Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM).
• 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.

Nice to have

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

What the company offers

• Competitive salary and extensive benefits package.
• Flexible working environment valuing work-life balance.
• Career development opportunities.

About the company

Johnson & Johnson operates under its Credo, emphasizing responsibility to its employees. The company fosters an inclusive work environment where each person is considered as an individual. It respects the diversity and dignity of its employees and recognizes their merit.

• Guided by its Credo and is responsible to its employees.
• The company provides an inclusive work environment where each person is considered as an individual.
• The company respects the diversity and dignity of its employees and recognizes their merit.