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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Beijing, China, Shanghai, China
Job Description:
Position Summary:
The Senior Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures.
Principal Responsibilities:
Quality and Compliance Oversight Activities
- Monitor compliance risk and ensure mitigation/remediation actions are defined.
- Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities: Conduct Compliance Monitoring Visits. Perform assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial. Planning and execution of local QC checks。 Support and advise local and central study teams in root cause analysis of significant observations.
- Ensure appropriate filing of the QC reports. Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
- Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed.
- Collaborate with local and central business partners in timely CAPA setting and implementation. Provide CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.
- Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents.
Local Onboarding and Consultation
- Support onboarding of new hires.
- Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc.
- Provide advice regarding SOP, system and GCP questions of low complexity.
- Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
Local regulatory intelligence
- Perform impact assessments of new/revised local regulations, guidance, and standards.
- Support central functions in ensuring local intelligence is up to date (e.g., CLRR).
Collaboration with Business Quality
- Support LOC Management Review in collaboration with LOC Commercial Quality partners.
- Support local suppliers’ assessments as appropriate.
- Support annual Due Diligence update, certification, and training of local suppliers, if applicable
Principal Relationships:
The Senior Compliance Specialist reports into the Associate Director, Compliance Lead, China. Is a member of the regional Compliance team.
Education and Experience Requirements:
Education
A minimum of a bachelor’s degree in science (BSc) or Medicine or minimum 5 years’ relevant experience equivalent is required. At least 4 years of site/trial management experience is required. Experience in quality/compliance, on-site inspections, or audits is preferred.
Related Experience
- Knowledge of the overall drug development process.
- Developing skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities).
- Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
- Ability to translate data into information and strategies into executable action plans improving the business.
- Conflict resolution/management and negotiation skills.
- Ability to plan, organize, coordinate, manage and execute assigned tasks, with support of peers and manager as needed.
- Experience of the key customers’ business processes and practices.
- Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
- Experience with regulatory submissions (NDA, BLA) is an asset.
General Skills
- Problem solver
- 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 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. - Typically has smaller scope projects. – Manages and/or leads limited number of projects of low complexity - Contributes to local and regional strategy.
- Nature of Communication - May influence or persuade others within area of immediate responsibility, scope, and level to accept new ideas, approaches, and concepts.
- Innovation: - Identifies issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope.
Other skills and Abilities
Requires limited supervision. Possess good written, oral communication, interpersonal skills, diplomacy, and presentation skills and customer service.
Other:
- Excellent knowledge of English is required.
- Proficient in Microsoft Office applications
Required Skills:
Preferred Skills:
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics