Senior Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D OperationsJob Sub Function:
Clinical Trial Project ManagementJob Category:
ProfessionalAll Job Posting Locations:
Beijing China Shanghai ChinaJob 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 bachelors 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 EthicsRequired Experience:
Senior IC
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
