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:

R& D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, 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 Lead Compliance Specialist to be located in Raritan, NJ; Titusville, NJ; Horsham, PA, Spring House, PA or Malvern, PA.

Purpose: The Lead Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures.

You will be responsible for:

• Monitoring compliance risk and ensuring mitigation/remediation actions are defined.
  
• Monitoring progress and confirming effectiveness of remediation plans, by performing Quality Control (QC) checks or special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:
  • Conducting compliance monitoring visits.
  • Performing assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial.
  • Planning and execution of local QC checks
  • Supporting and advising local and central study teams in root cause analysis of significant observations.
  • Ensuring appropriate filing of the QC reports.
    
• Supporting Quarterly Quality Reviews with local Global Clinical Operations (GCO) management addressing compliance issues and risk signals.
  
• Collaborating with local and central business partners to facilitate (local) inspections and office audits as needed.
  
• Collaborating with local and central business partners in a timely CAPA setting and implementation.
  
• Providing CAPA Champion support.
  
• Supporting the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents.
  
• Supporting onboarding of new hires.
  
• Managing local workshops to support Quality Management Systems (QMS) and compliance awareness, Lessons Learned, etc.
  
• Providing advice regarding SOP, system and Good Clinical Practices (GCP) questions of moderate complexity.
  
• Supporting managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
  
• Performing impact assessments of new/revised local regulations, guidance, and standards.
  
• Supporting central functions in ensuring local intelligence is up to date (e.g., Country Level Regulatory Requirements-CLRR).
  
• Supporting Local Operating Company (LOC) Management Review in collaboration with LOC Commercial Quality partners.
  
• Supporting local suppliers’ assessments as appropriate.
  
• Supporting annual Due Diligence update, certification, and training of local suppliers, if applicable.
  
  

Qualifications / Requirements:

Education:

• A minimum of a Bachelor degree is required. An advanced degree is preferred.

Experience and Skills:

Required:

• 4+ years of Pharmaceutical industry experience is required, with at least 3 years of GxP experience within clinical research and development and/or quality assurance.
  
• Knowledge of the overall drug development process is required.
  
• Knowledge of business processes and practices (i.e., SOPs governing clinical research activities) is required.
  
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is required.
  
• Ability to translate data into information and strategies into executable action plans improving the business is required.
  
• Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development is required.

Preferred:

• Ability to motivate professional colleagues and partners is preferred.
  
• Conflict resolution/management and negotiation skills is preferred.
  
• Ability to independently plan, organize, coordinate, manage and complete assigned tasks is preferred.
  
• Experience of the key customers’ business processes and practices is preferred.
  
• Experience with regulatory submissions (NDA, BLA) is an asset.
  
• Proficiency in Microsoft Office applications is preferred.

The anticipated base pay range for this position is $105, 000 to $169, 050.

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.

• Employees and/or eligible dependents may be 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.
  
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
    
• Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits

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.

This job posting is anticipated to close on 08/12/2025. The Company may, however, extend this time-period, in which case the posting will remain available on https: //www.careers.jnj.com 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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

#LI-Onsite

The anticipated base pay range for this position is:

The anticipated base pay range for this position is $105, 000 to $169, 050.

Additional Description for Pay Transparency: