SENIOR SPECIALIST, CLINICAL RISK MANAGEMENT - NEUROSCIENCE

Janssen Research & Development, LLC, a member of the Johnson & Johnson family of companies, is recruiting for a Senior Specialist, Clinical Risk Management - Neuroscience.
The preferred and primary location is Horsham, PA.
Consideration may be given for candidates to be located at our Janssen R&D offices in Raritan, NJ, Titusville, NJ, Beerse, BE, Allschwil, CH, or Leiden, NL.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
We are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more at www.
anssen.
om and follow us @JanssenGlobal.
Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
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.
nj.
om/.
The Senior Specialist works with the trial 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 Senior Specialist 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.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! 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 IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews Actively identifies and raises new central risk concerns to management to support collaboration and efficiencies Provides independent 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.
Provides guidance for significant quality issues (SQI) per corporate standards and brings up to senior R&D management.
In collaboration with partners in R&D Quality, 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 inspections including post inspection support for sites, sponsor and third parties (vendors, co-development partners and contract research organizations) Support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan.
Participates in Clinical Risk Management, R&D Quality, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member).
Qualifications A minimum of a Bachelor's degree is required.
Focus degree in Science, Medical, or related field is preferred.
A minimum of 6 years of experience working in the healthcare industry, pharmaceutical industry, contract research organization and/or healthcare/hospital system is required GCP quality and/or clinical trials experience is required Excellent interpersonal, oral, and written communication skills are required Experience collaborating in a cross-functional team environment is required Flexibility to respond to changing business needs is required Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) is preferred Experience with fundamentals of clinical trial risk management is preferred Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance) is preferred Experience working to ICH guidelines is preferred Health Authority Inspection experience (FDA, EMA and other inspectorates) is preferred Strong Project Planning/Management skills is preferred Experience and/or proficiency with data analytics and/or data visualization tools (i.
., Tableau, Spotfire, or related) is preferred Proven ability to analyze & interpret collective data to provide insights to drive decision-making is preferred Experience in managing escalations and CAPA support/advisement is preferred Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred The preferred and primary location is Horsham, PA.
Consideration may be given for candidates to be located at our Janssen R&D offices in Raritan, NJ, Titusville, NJ, Beerse, BE, Allschwil, CH, or Leiden, NL.
This position may require up to 10% domestic & international travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
The anticipated base pay range for this position is $ to $.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits.
• Vacation – up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year • Holiday pay, including Floating Holidays – up to 13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to.
- https://www.
areers.
nj.
om/employee-benefits.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
This job posting is anticipated to close on .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
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