Lead Compliance Specialist GCP

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Issy-les-Moulineaux, France

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

Johnson & Johnson is currently seeking a Lead Compliance Specialist to join our Compliance Team located in Issy-les-Moulineaux, France .

1 day a week office presence is required.

Position Summary:

This position is responsible for performing activities within the assigned portfolio (e.g.

process(es); primarily for GCO, but may include support for other functional, department(s), where relevant) that (1) ensure an integrated and comprehensive compliance approach for clinical trials in close collaboration with local and global functions (e.g.

Quality, Privacy, HCC, Legal, Global/Local Medical Safety, and Operations), and (2) ensure clinical trials are performed in compliance with relevant laws and regulations, industry standards and Johnson & Johnson processes and procedures.

Principal Responsibilities:

Compliance Oversight

1) Monitor compliance risk and ensure mitigation/remediation actions are defined.

2) Monitor progress and confirm effectiveness of remediation plans, e.g.

by performing 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, and depending on the assigned portfolio, may perform the following risk-based activities:

• Conducting Compliance Monitoring Visits.

• Performing relevant reviews, such as Trial Master File, training compliance documentation and

other checks per the defined strategy.

• Planning and execution of compliance checks.

• Supporting and advising...