Sr Specialist Ed Risk Management

il y a 3 semaines

Beerse, Belgique Johnson & Johnson Temps plein

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.

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

**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 6 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

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