Johnson & Johnson Careers
HEAD RISK MGT CENTRAL MONITORING
Requisition ID: 0300190326
- Supervise, provide day-to-day guidance and support to functional managers, as well as Systems and Analytical core members on team in order to:
- Develop functional goals and objectives that are aligned with the function / business support team goals and objectives
- Provide an environment for professional growth of staff which includes actionable feedback, recognition and rewards
- Provide coaching and mentoring in support of the staff’s development
- Ensure continued growth in the broader Janssen R&D organization
- Reports to VP, Head of IDAR
- Contacts inside the company may include: Janssen R&D Operations functions, GCDO regional and other central organizations, Janssen R&D IT
- Contacts outside the company may include: External vendors as necessary, other pharma companies’ representatives in e.g. TransCelerate, PhUSE, Health Authority representatives
EDUCATION AND EXPERIENCE REQUIREMENTS:
A minimum of a Bachelor of Science (BSc) degree is required; Masters Degree or equivalent with a focus on operation and risk management is preferred.
A minimum of 10 (ten) years of experience in a medium to large scale matrix pharma or CRO with experience in risk management in clinical development; compliance and/or clinical operations background in a related R&D area is required.
Knowledge of ICH-GCP and overall drug development processes is required.
Expert knowledge of major national and international (e.g. ICH, FDA, MHRA, European Directive, etc…) regulations and guidelines related to clinical development is required.
Proven skills in process development and risk management including risk identification and mitigation. Experience in developing quality risk management tools / metrics is required.
Proven experience in people leadership/ management including talent development, performance management, and building diverse, effective teams is required.
Extensive experience with audits (investigative sites, systems, vendors) and regulatory inspections is required.
Problem solver, proactive strategic thinker, strong leader and collaborator.
Motivated to present at external venues to further solidify RM-CM in the pharmaceutical development environment.
Highly committed to quality, flexible and persistent.
Strong people management skills, with ability to select, motivate and develop professional colleagues fitting the organization.
Good conflict handling/negotiation skills, ability to independently plan, organize, co-ordinate, manage and execute assigned tasks, excellent communicator, with excellent interpersonal skills and diplomacy.
Proficient in Microsoft Office applications.
Excellent knowledge of English is required.
Able to create win-win situations with internal and external partners.
United States-New Jersey-Raritan-
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Florida-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination