Description
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 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:
QualityJob Sub Function:
Clinical QualityJob Category:
ProfessionalAll Job Posting Locations:
Beerse, Antwerp, BelgiumJob 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 Senior Specialist, Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Beerse, Belgium.
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-077212
United Kingdom - Requisition Number: R-080509
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Purpose:
The Senior Specialist, Clinical Risk Management, works with the trial teams to coordinate the identification, assessment, and mitigation of quality risks that
could impact trial data integrity, patient safety, well – being, or rights. Throughout the duration of the trial, the Senior Specialist executes data-driven, risk-based trial oversight activities to deliver quality in the execution of trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.
Key responsibilities:
Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies
Participates in regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned)
Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
Highlight new potential systemic risk to RDQ CRM management
Develops and ensures a consistent interpretation of issues that require quality investigations
Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensures availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
Provides advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
Qualifications:
A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required
A minimum of 6 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required
Excellent interpersonal, oral, and written communication skills
GCP quality and/or clinical trials experience
Experience collaborating in a cross-functional team environment
Flexibility to respond to changing business needs is required
Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required
Proficiency in Microsoft Office Applications is required
Experience with fundamentals of clinical trial risk management, preferably in a global setting
Experience working to ICH guidelines
Health Authority Inspection experience (FDA, EMA and other inspectorates)
Strong Project Planning/Management skills
Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
Proven ability to analyze & interpret collective data to provide insights to drive decision-making
Experience in managing escalations and CAPA support/advisement
Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
Requires proficiency in speaking and writing English.
Up to 10% travel, primarily domestic with some international travel
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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Audit Management, Business Alignment, Business Savvy, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Compliance Management, Data Analysis, Escalation Management, Fact-Based Decision Making, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Tactical Thinking, Vendor SelectionThe anticipated base pay range for this position is:
€72,500.00 - €115,230.00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
