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Manager, Early Development Risk Management - 2306121473W

Description

Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Early Development Risk Management within our BioResearch Quality & Compliance (BRQC) organization! Remote work options may be considered on a case-by-case basis and if approved by the Company.

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.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our innovative products? Apply today for this exciting opportunity!

The Manager will support the Early Development (ED) phase of clinical research. They are responsible for working with trial teams to support and/or coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well-being, or rights. Throughout the duration of the trial, they support data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials, compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Key Responsibilities:

• Actively participate in all study activities, positively supporting the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies

• Collaborate with Risk Owners to support regular review of risk areas to evaluate progress of mitigations and risk reduction, and to identify potential new risks or additional mitigation needs for their assigned trials

• Communicate risk updates through cross-functional trial-level meetings and/or Quality Working Groups and Governance Fora, as applicable

• Identify potential systemic and/or significant quality issues (SQI) per corporate standards and communicate these to senior R&D management

• Provide initial serious breach evaluation of quality issue that may require reporting to Health Authorities

• In collaboration with partners in BRQC, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self-Identified, Inspection, and Audit)

• Support ongoing inspection readiness activities to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinate mock inspections with Regulatory Compliance teams

• Provide supervision and/or coaching for others on inspection support and readiness

• Guide on questions related to research quality from Business Partners alongside other Quality Professionals to ensure consistent interpretation of international regulations and policy

• Positively participate in working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions

• With the guidance from the Licensing & Acquisition (L&A) Team and ED/Oncology Head or Delegate, 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 implement assigned responsibilities per plan

• Provide input into Quality Agreements with (Co-)development Partners and complete responsibilities per agreement

Qualifications

Education:

• Minimum of a Bachelor's or equivalent University Degree required; advanced or focused degree in Science, Medical, or related field preferred

Experience and Skills:

Required:

• Minimum 8 years of relevant work experience

• Experience working in the Healthcare Industry (e.g., Pharmaceutical industry, contract research organization, or healthcare/hospital system)

• Proven strong GCP Quality and/or clinical trials experience

• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment

• Flexibility to respond to changing business needs

• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures

• Proficiency in Microsoft Office Applications

Preferred:

• Experience with fundamentals of clinical trial risk management

• Experience working to ICH guidelines

• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP)

• Health Authority Inspection experience (FDA, EMA, and other inspectorates)

• Oncology Drug Development experience

• Strong Project Planning/Management skills

• Experience in managing escalations and CAPA support/advisement

• 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

• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)

Other:

• Requires proficiency in speaking and writing English

• Requires up to 10% travel, primarily domestic with some international travel

The anticipated base pay range for this position is $97,000 USD to $166,750 USD. For candidates in the San Francisco Bay area - $111,200 USD to $191,820 USD.

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; 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

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits_ _.

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 .

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.

Primary Location NA-US-New Jersey-Raritan

Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands, NA-US-New Jersey-Titusville

Organization Janssen Research & Development, LLC (6084)

Travel Yes, 10 % of the Time

Job Function Compliance

Req ID: 2306121473W