Submissions & Regulatory Intelligence Manager (Clinical Data Standards)

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 https://www.jnj.com

Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Clinical Data Management

Job Category:
Professional

All Job Posting Locations:
Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Submissions & Regulatory Intelligence Manager

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 (hybrid) located within commutable distance of High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; Bangalore or Hyderabad, India; Springhouse or Titusville NJ, United States.

Purpose:

Contributes to the Clinical Data Standards team as an individual contributor who is a developing subject matter expert, and who works independently with minimal supervision and who takes a leadership role in the collaboration with various internal and external partners.

Consults on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy.

Applies in-depth knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area.

Ensures consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

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 re...