Senior Specialist, Clinical Risk Management

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:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

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 Senior Specialist, Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in High Wycombe, UK.

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

Belgium - Requisition Number: R-080508

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 thetrialteamstocoordinatetheidentification, assessment,and mitigation ofquality risks that

couldimpacttrial data integrity, patient safety,well-being,or rights.Throughout the duration of the trial, theSenior Specialist executes data-driven, risk-based trial oversight activities to deliver quality in the execution oftrials (and/or programs),compliance with regulatory requirements and internal procedures, and tomaintaina continued state of inspection readiness.

Key responsibilities:

• Activelyparticipatesinallstudy 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 inregular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and toidentifypotential new risks oradditionalmitigation needs (trial and/or compound, as assigned)

• Maintains CQP (Clinical Quality Plans) in quality repository tofacilitateregular progress reviewsof quality support services in addition to risks and mitigations

• Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations

• Communicatesandfacilitatesrisk updates to R&D colleagues as part of the regular review cyclethrough Quality Working Groups and Governance Fora, as applicable(trial and/or compound, as assigned).

• Highlight new potential systemic risk toRDQCRMmanagement

• 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 inRDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self -Identified, Inspection, Audit)

• Supportsproactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives,identifyand prepare sites of interest for inspection (including, pre-inspection visit support), ensuresavailability of key documents/recordsand coordinatesmock inspectionincollaboration with RegulatoryCompliance teams.

• Provides supportfor Investigator, Sponsor-Monitor and third-party inspections includingpost inspection support

• Providesadvice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals andSubject 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,EMAand other inspectorates)

• Strong Project Planning/Management skills

• Experience and/orproficiencywith 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 Selection