Regulatory Submissions & Data Standards Lead

Johnson & Johnson Innovative Medicine; Raritan (NJ); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Performance bonus

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Vacation 120 hours

Job summary

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager within IDAR to contribute to the Clinical Data Standards team as an individual contributor and SME, leading collaboration with internal and external partners to ensure consistent data standards across trials and regulatory compliance.

The role requires expert knowledge of RHA guidance, SDTM/ADaM, and regulatory submission requirements, with responsibilities spanning the lead of submission readiness

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline or equivalent experience.
• At least 6 years of relevant pharmaceutical/scientific experience.
• Expert knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Experience with regulatory submissions (NDA, BLA) is an asset.
• Strong written and verbal communications skills.

Responsibilities

• Act as top-level specialist to establish programs and innovative strategies for Clinical Data Standards.
• Manage standards, projects, programs, or processes for Clinical Data Standards.
• Develop solutions to provide accurate, timely, and consistent clinical data standards to study teams.
• Coach and train junior colleagues in clinical data standards application.

Skills

Leadership

Communication

English proficiency

Interpersonal skills

Customer focus

Education

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

Advanced degrees preferred (Master, PhD)

Job description

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager within IDAR to contribute to the Clinical Data Standards team as an individual contributor and SME, leading collaboration with internal and external partners to ensure consistent data standards across trials and regulatory compliance.

The role requires expert knowledge of RHA guidance, SDTM/ADaM, and regulatory submission requirements, with responsibilities spanning the lead of submission readiness