Lead Compliance Specialist

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:
Quality

Job Sub Function:
Clinical Quality

Job Category:
Professional

All Job Posting Locations:
Toronto, Ontario, Canada

Job Description:

We are searching for the best talent for our Lead Compliance Specialist position to be located in Toronto, Ontario, Canada.

Remote work options will be considered on a case-by-case basis and if approved by the Company.

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

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.


* Collaborat...