Senior Manager / Associate Director, Standards Technical Integration Lead - 2 openings

Overview

Remote
On Site
USD 137,000.00 - 235,750.00 per year
Full Time

Skills

Spectrum
Computational Science
Jersey
Science
Data Analysis
Regulatory Compliance
Spring Framework
Data Collection
Reporting
Corporate Social Responsibility
Data Science
Collaboration
Health Care
Pharmaceutics
Data Management
Biostatistics
SDTM
Customer Focus
Leadership
Decision-making
Problem Solving
Conflict Resolution
English
Law
Advanced Analytics
Clinical Data Management
Clinical Trials
Privacy
Data Quality
Good Clinical Practice
Google Cloud
Google Cloud Platform
Innovation
Learning Management
LMS
Organizational Skills
Program Management
Regulatory Affairs
Management
Research
SAP BASIS
Life Insurance
Legal
Insurance
Military

Job Details

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 ;br>
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 ;br>
We are searching for the best talent for a Standards Technical Integration Lead within Integrated Data Analytics & Reporting (IDAR), to contribute to the Clinical Data Standards team as a leading expert individual contributor, guiding the execution of projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy.

Purpose:

The Standards Technical Integration Lead applies comprehensive knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

The role may be located in Titusville, NJ / Raritan, NJ /Spring House, PA, US; High Wycombe, United Kingdom; Allschwil, Switzerland; Beerse, Belgium; Leiden, Netherlands; Hyderabad / Mumbai, India (Hybrid / 3 days onsite per week preferred).

Please note that this role is 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):

United States - Requisition Number: R-046101

United Kingdom -Requisition Number: R-048105

Switzerland - Requisition Number: R-0488112

Belgium/Netherlands/India - Requisition Number: R-048107

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

You will be responsible for:

Job Description

Standards Technical Integration Lead is responsible for applying the strategy and tracking development of standards across the full data lifecycle from data collection through to submission, including standards for CRF, SDTM, ADaM, Reporting, CSR, etc. This may include adjacent data standards like FHIR and OMOP. This role will analyze requests, assess the impact across the lifecycle, and orchestrate changes across standards teams to deliver a holistic set of standards.

The position prepares trainings for trial teams on standards to ensure understanding and alignment across the full data lifecycle.

Standards Technical Integration Lead is positioned as a leader of the full standards process to ensure successful standards implementation.

Principal Relationships:

Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Clinical Data Standards and others as needed.

External: Interact and collaborate with vendors. Act as J&J representative for defining process standards and sharing best practices with industry counterparts and working groups, as required.

Education and Experience Requirements:

  • A bachelor's degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD)
  • At least 8 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., Google Cloud Platform, ICH) and industry standards (e.g., SDTM, ADaM)
  • 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

For United States applicants only:

The expected base pay range for this position in the US is $137,000 to $235,750 (USD).

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.

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)).

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 period 10 days
  • Volunteer Leave - 32 hours per calendar year
  • Military Spouse Time-Off - 80 hours per calendar year

For additional general information on company benefits, please go to: ;br>
This job posting is anticipated to close on January 5, 2026. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

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, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:
Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (Google Cloud Platform), Innovation, Issue Escalation, Learning Management Systems (LMS), Leverages Information, Organizing, Program Management, Regulatory Affairs Management, Research Ethics, Technical Credibility

The anticipated base pay range for this position is :
$137,000-$235,750

Additional Description for Pay Transparency:
The expected base pay range for this position in the US is $137,000 to $235,750 (USD). 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. 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)). 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 period 10 days - Volunteer Leave - 32 hours per calendar year - Military Spouse Time-Off - 80 hours per calendar year For additional general information on company benefits, please go to: ( This job posting is anticipated to close on January 5, 2026. The Company may however extend this time-period, in which case the posting will remain available on ( to accept additional applications.
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