At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com
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.
Job Function
Data Analytics & Computational Sciences
Job Sub Function
Clinical Data Management
Job Category
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description
About Innovative Medicine:
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 https://www.jnj.com/innovative-medicine
We 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 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-103242United Kingdom
Requisition Number:
R-101253Switzerland
Requisition Number:
R-103247United 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.
Purpose
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.
You Will Be Responsible For
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 Submissions & 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!Qualifications / Requirements
A Bachelor’s 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
Benefits
The expected pay range for this position is $117,000 - 201,250 USD.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills
Preferred Skills:
Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Innovation, Leverages Information, Process Improvements, Regulatory Affairs Management, Research Ethics, Technical Credibility
The anticipated base pay range for this position is :
