Associate Dir. Cross TA Risk Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Horsham Pennsylvania United States of America Raritan New Jersey United States of America Spring House Pennsylvania United States of America Titusville New Jersey United States of America

Job Description:

Johnson & Johnson is currently seeking an Associate Director Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House PA; Horsham PA; Titusville NJ; Raritan NJ; Beerse Belgium; Basel Switzerland; High Wycombe UK; Madrid Spain.

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 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-083139

Switzerland - Requisition Number: R-085157

United Kingdom - Requisition Number: R-085163

Belgium/Madrid - Requisition Number: R-085167

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Job description to follow:

The Associate Director Cross TA Clinical Risk Management works with the trial teams and/or Program teams to coordinate the identification assessment and mitigation of quality risks that couldimpact ontrial data integrity patient safetywell being or the duration of the trial/program this Associate Director executes data-driven risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs) compliance with regulatory requirements and internal procedures and tomaintaina continued state of inspection readiness.

Key responsibilities:

• Actively and independently participatesin allstudy 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 for complex clinical trials compounds and programs.
• Leads regular 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
• Independently drives quality risk monitoring reviews andcoachesothers on risk monitoring and mitigation reviews
• 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.
• 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)
• Drivesongoing inspection readiness activities with trial teams to develop inspection narrativesidentifyand prepare sites of interest for inspection (including pre-inspectionvisitsupport) ensure availability of key documents/recordsand coordinatesmock inspectionincollaboration with RegulatoryCompliance teams.
• Provides supportfor Investigator Sponsor-Monitor and third-party inspections includingpost inspection support
• Providesindependent adviceon questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals andSubject Matter Experts to ensure consistent interpretation of international regulations and policy.
• Participates in Clinical risk Management cross R&D quality cross functional and cross sector working groups to develop or refine processes tools and systems that deliver innovative quality solutions
• Provides training and coaching to peers and new employees as needed

Qualifications:

• A minimum of a Bachelors degree (scientific medical or related discipline) is required.
• A minimum of 8 years working in the healthcare industry (pharmaceutical industry contract research organization and/or healthcare/hospital system) is required.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal oral and written communication skills to effectively collaborate in a cross-functional team environment is required.
• 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 is required.
• Experience working to ICH guidelines is required.
• Knowledge of Good Manufacturing Practice (GMP) Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA EMA and other inspectorates) is required.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e. Tableau Spotfire or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• 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 internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$122000.00 - $212750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

IC