Submissions & Reg. Intelligence Mgr

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Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function:
Data Analytics &Computational Sciences

Job Sub Function:
Clinical Data Management

Job Category:
Professional

All Job Posting Locations:
Allschwil, Basel-Country, Switzerland

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We are searching for the best talent for a Submissions & Reg Intelligence Manager within Integrated Data Analytics & Reporting (IDAR), to contributes to the Clinical Data Standards team as an individual contributor and a developing subject matter expert, to take a leadership role in the collaboration with various internal and external partners. The Submissions & Reg 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. 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). Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Belgium/Netherlands

- Requisition Number: R‑103242 United Kingdom

- Requisition Number: R‑101253 Switzerland

- Requisition Number: R‑103247 United States
- Requisition Number: R‑103251 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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.