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:
Pefki, Attiki, Greece
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 team located in Pefki, Greece. This position is a hybrid role - 3 days in the office, 2 days home office.
The Lead Compliance Specialist is responsible for performing activities within the assigned country 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.
Key Responsibilities:
Quality and Compliance Oversight Activities
Monitor compliance risk and ensure mitigation/remediation actions are defined.
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.
Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed.
Collaborate with local and central business partners in timely CAPA setting and implementation. Moderate level of risk awareness and ability to translate risks into actions.
Local Onboarding and Consultation
Support onboarding of new hires.
Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc.
Provide advice regarding SOP, system and GCP questions of moderate complexity.
Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
Qualifications:
Education
A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 5-6 years relevant experience equivalent is required. A minimum of 4 years of previous Pharmaceutical Industry experience is required, with at least 3 years of GCP experience within clinical research and development and/or quality assurance.
Experience and Skills:
Required:
Knowledge of the overall drug development process.
Developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities).
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions.
Ability to translate data into information and strategies into executable action plans improving the business.
Ability to motivate professional colleagues and stakeholders.
Conflict resolution/management and negotiation skills.
Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
Experience of the key customers’ business processes and practices.
Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
Preferred:
Other:
Required Skills:
Clinical Compliance, Drug Development, GCP Auditing, Negotiation
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)