Associate Dir. Cross TA Risk Management

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:

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 https://www.jnj.com/innovative-medicine

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-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 could impact on trial data integrity, patient safety, well – being, or rights. Throughout 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 to maintain a continued state of inspection readiness.

Key responsibilities:

Actively and independently 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 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 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

Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews

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.

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)

Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure 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 independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject 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 Bachelor’s 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 https://www.jnj.com/contact-us/careers , 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 :

$122,000.00 - $212,750.00

Additional Description for Pay Transparency:

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

This position is eligible to participate in the Company’s 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: - https://www.careers.jnj.com/employee-benefits