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Quality

ONCOLOGY RISK MANAGER

  • 標題 ONCOLOGY RISK MANAGER
  • 功能 Quality
  • 子功能 Clinical Quality
  • 類別 Manager, Clinical Quality (P7)
  • 位置 Spring House, Pennsylvania, United States; Community of Madrid, Spain; Issy Les Moulineaux, Haute-de-Seine, France; Raritan, New Jersey, United States; Horsham, Pennsylvania, United States; Somerville, New Jersey, United States; Titusville, New Jersey, United States; Malvern, Pennsylvania, United States; Wayne, Pennsylvania, United States; Beerse, Antwerp, United States; High Wycombe, England, United States
  • 刊登日期
  • 參考 2406184745W
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描述

Janssen Reseach and Development LLC is recruiting for an Oncology Risk Manager, located in Spring House, PA, Beerse, Belgium, Madrid, Spain, Issy Les Moulineaux, France, High Wycome, Great Britain, Malvern, PA, Wayne, PA, Somerville, NJ, Horsham, PA, Raritan, NJ or Titusville, NJ!

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.jnj.com/.

The MANAGER (ONC 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 MANAGER 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:

  • Development and management of Integrated Quality Plans (IQPs)
  • Work with risk and mitigation owners to control risks identified in the IQP
  • Provide input into compound and trial strategies to ensure risks are identified and mitigated early
  • Lead Quality Working Group meetings (QWGs) to define and refine the IQP
  • Lead the escalation of and resolution of significant quality issues
  • Lead inspection readiness activities, manage site inspections and assist in the facilitation of Sponsor Monitor inspections
  • Act as CRM single point of contact for cross-functional and clinical trial teams and provide support on GCP/quality issues
  • Conduct quality reviews of documents, as required
  • Conduct ad hoc quality checks of trial TMFs
  • As required, support the quality integration of post-licensing and acquisition assets

資格

Education:

  • A minimum of a Bachelor's or equivalent (Scientific, medical, or related subject area)

Experience and Skills:

Required:

  • A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required
  • Proficiency in Microsoft Office Applications
  • Proficiency in speaking and writing English
  • Excellent interpersonal, oral, and written communication skills
  • Proven strong GCP quality and/or clinical trials experience
  • Experience collaborating in a cross-functional team environment
  • Flexibility to respond to changing business needs
  • Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures

Preferred:

  • Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
  • Specific Therapeutic Area experience may be required depending on the position.
  • Experience with fundamentals of clinical trial risk management
  • Global clinical trial experience
  • Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)
  • 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)

Other:

  • This position is anticipated to have 10% travel
  • The salary for this position, if located in the United States, is aniticipated to be between $95,000 to $150,000

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)).
  • This position is eligible to participate in the Company’s long-term incentive program.
  • 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; for employees who reside in the State of Washington – up to 56 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

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.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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