Submissions & Reg. Intelligence Mgr

Johnson & Johnson•Titusville, PA

13d•Hybrid

About The Position

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. 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 contribute 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-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.

Requirements

A 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; 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

Nice To Haves

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

Responsibilities

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.
Provides significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies.
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.
Acquires and maintains 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).
Supports the ownership by SRI of any tools, system, checklists templates, etc., that facilitate data package compliance checking for IDAR.
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.

Benefits

medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
consolidated retirement plan (pension) and savings plan (401(k)).
long-term incentive program.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year