Regional Compliance Associate Director - Informed Consent Process Owner

Within the Global Clinical Operations organization, we are looking for a

Associate Director, Regional Compliance Manager - Informed Consent Process Owner

The Regional Compliance Associate Director is responsible for performing quality and compliance assessments in the region to ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures. Works in a collaborative manner with business partners to ensure compliance-related issues are reported to enable risk remediation actions that will result in in-process inspection readiness. Liaises with local study teams and central study team including BRQC partners and provides appropriate support to ensure optimal root cause analysis and follow-up of significant findings. Assists in the facilitation of inspections by regulatory authorities for GCP, supporting BRQC as appropriate.

In addition, this role will serve as the Informed Consent Process Owner for approximately 2 years.

As the Informed Consent Process Owner, this role will serve as process expert and leader focused on optimizing the quality and performance of this process lead the Janssen R&D Informed Consent Process Ownership in Global Development in collaboration with internal and external stakeholders. The IC Process Owner will define and ensure execution of a prioritized portfolio of process improvement projects with a current focus area of advancing the adoption of electronic and/or remote consent in alignment with Trials2You principals.

More specifically, the duties for the ICF Ownership include:

• Process Ownership of the Janssen R&D Informed Consent Process
• Responsible to remain aligned with the GD Process Governance through partnership with Business Process Optimization (BPO)Responsible for continuous improvement of internal creation and approval process of trial specific Informed Consent Forms (ICF) measured by quality, cycle time and patient and investigational site experience
• Facilitates flow-up of innovative ideas and supports cross-functional innovation programs related to Informed Consent
• Creates and oversees appropriate metrics which measure contribution and success to timely study/site start up activities and capture if the ICFs, including ICF amendments, are implemented in a timely manner on a site level
• Owns process level CAPA resolution
• In partnership with other organizations, deploys and oversees the Electronic Informed Consent capability across the Janssen R&D and Medical Affairs portfolio (both conducted internally and outsourced).
• Creates a feedback loop to understand patient and investigational site experience with Janssen’s Informed Consent process. Identifies areas for improvement and implements solutions in partnership with CIE.
• Co-develops and manage procedural documentation maintaining Global Master templates ensuring quality, compliance, simplicity and an enhanced patient and investigational site experience.
  • Develops specialized templates based on patient/site needs
  • Ensures continuous improvement of Informed Consent Process related documents (FRMs, Templates, Trackers, Summary Documents, Job Aides, etc) with focus on simplification
• Creates and oversees the process for issue escalation specific to mandatory ICF text changes received from EC/IRBs and/or HAs
• Maintains a global log and regularly communicates FAQs and Best Practices to key stakeholders
• Partners closely with the Informed Consent Quality Owner ensuring that all procedural documents are kept up-to-date, in line with global and regulatory requirements
• Develops an efficient network of SME’s on the associated Informed Consent processes to ensure proper support of business questions
• Identifies and drives training needs in collaboration with BRQC, regular maintenance/update
  • Work Instructions, Job Aid, Project Operating Manual (POM), Associated sponsorship and contact lists
• Partners closely with Local Affiliates (Local Compliance, LTM), Clinical Trial Manager (CTM), Medical Expense Reimbursement (MER), Central Insurance Group (CIG), Corporate Risk Management, Privacy, Biomarker and appropriate TA representatives (Study Responsible Physician, Project Scientist), Process Management, Legal (global), GD Trial Leader (GTL), GD Program Leader (GPL), QP&S, CCS, PARiS, Pediatric COE Rep, PRC members (Neuro and ONC), Protocol template owners, CROs (Alliance and non-Alliance), AROs and Advocacy Groups

Flexible location.

Qualifications

Education:
A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 8-10 years relevant experience equivalent is required. A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 4-6 years of GxP experience within clinical research and development and/or quality assurance and prior ICF strategy and development experience is required.

Mandatory background in clinical trials (Master or experience)

Related Experience:

• Extensive knowledge of the overall drug development and Informed Consent process
• Advanced skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities). Well-developed skills working cross-functionally.
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Leads the translation of data into information and strategies into executable action plans improving the business
• Motivates professional colleagues and stakeholders
• Conflict resolution/management and negotiation skills
• Independently plans, organizes, coordinates, manages and executes assigned tasks
• Experience of the key customers’ business processes and practices
• Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development and Informed Consent;
• Experience with regulatory submissions (NDA, BLA) is an asset;
• Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences;
• Experience in R&D process requirements to successfully drive compliance productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• Demonstrated project leadership skills
• Manages or leads multiple projects, including some considered complex and/or with accelerated priority, beyond immediate country responsibilities in support of regional/global Compliance/GCO projects.
• Demonstrated competence for team leadership and/or people management.
• Individual contributor with leadership ability
• May serve as a back-up for Regional Compliance Leader
• Mandatory experience in international projects.

General Skills:

• Problem solver
• Proactive strategic thinker
• Strong leader and collaborator
• Highly committed to quality and compliance
• Flexible and persistent
• Good conflict handling/negotiation skills
• Able to create win-win situations with internal and external partners
• Knowledge of the corporate structure and culture
• Impact - Complexity and Scope: Contributes significantly to the definition and development of new processes, standards or operational plans in support of the organizational/business strategies, with a direct impact on business unit/function overall results. May have direct responsibility and accountability for project budgets and/or functional budgets. Typically has responsibility for projects of moderate-size complexity and business impact, such as accountability for regional and/or multi-functional scope. Manages or leads multiple projects, including some considered complex and/or with accelerated priority. Contributes significantly to local, regional and/or global strategy.
• Nature of Communication: Influences or persuades others often beyond area of immediate responsibility, scope and level to accept new ideas, approaches and concepts that challenge the status quo. Interacts and collaborates with internal and external colleagues with coordination between departments. May represent J&J or company externally with limited supervision. May cultivate and leverage strategic networks and partnerships.
• Innovation: Proactively anticipates complex issues; exercises considerable judgment in enhancing business/work processes, developing new approaches/novel solutions and resolving issues beyond immediate area of responsibility and scope. Seeks to contribute to improving business/work processes.

Other Skills and Abilities: Requires little supervision and functions with a high level of autonomy. Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.

Other:

• Excellent knowledge of English is required
• Proficient in Microsoft Office applications

Primary Location
Spain— Other Locations
Netherlands, Switzerland, Italy, Russia, Belgium, Germany, France, United Kingdom, Ireland
Organization
Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Job Function
R&D
Requisition ID
2105889532W