Submissions & Regulatory Intelligence Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Submissions & Regulatory 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 & Regulatory Intelligence Manager provides expert guidance and implements tailored solutions on projects programs and processes that span multiple related areas in support of the organizations 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 & Johnsons Credo and Leadership Imperatives into team goals and decision making.

The Submissions & Regulatory Intelligence Manager is responsible for providing significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies. Examples of this content are:

• Newly released or updated Regulatory Health Authority (RHA) and industry guidance documentation
• Identification of clinical study data submission information critical to IDAR submission processes and procedures including providing an interpretation of such information if needed
• IDAR submission requirements and rules

The position serves as the single Point of Contact for any stakeholder on data management clinical and statistical programming and global regulatory affairs for data submission deliverable requirements and makes sure these teams have a very clear understanding of these deliverables the need for compliance the difference between RHA requirements and the general submission processes.

The Submissons & Regulatory Intelligence Manager is responsible for acquiring and maintaining deep expertise in current RHA and industry guidance and RHA validation/compliance rules in relation to data submission packages (e.g. SDTM/ADaM submission packages). The position supports the ownership by SRI of any tools system checklists templates etc. that facilitate data package compliance checking for IDAR.

The position may serve as the lead of the Submission Center of Excellence serving as POC for study teams requesting SubCOE support responsible for workload distribution amongst the team working at the trial level post-DBL to ensure SDTM ADaM and documentation submission-readiness.

Are you ready to join our team Then please read further!

• A Bachelors degree in a scientific technology or healthcare discipline or equivalent experience. Advanced degrees preferred (e.g. Master PhD)
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g. data management biostatistics clinical or statistical programming!
• Expert knowledge of relevant regulatory requirements (e.g. GCP ICH) and industry standards (e.g. SDTM ADaM)
• Experience with regulatory submissions (NDA BLA) is an asset
• 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

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation.

Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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