Job Information
J&J Family of Companies [Janssen] Local Compliance Specialist in Seoul, South Korea
[Janssen] Local Compliance Specialist - 2406186213W
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, 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 humanity.
Learn more at https://www.jnj.com/ .
포지션: Local Compliance Specialist
계열사: 얀센 (Janssen)
근무지: 서울시 용산구
근무 형태: Regular
[Summary]
The Local 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.
[Main 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 On-Site 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 Quality Event Management (QEM) 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 moderate 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., RIACS)
Collaboration with Business Quality
Support LOC Management Review in collaboration with LOC Business Quality partners
Support local suppliers assessments as appropriate
Support annual Due Diligence update, certification and training of local suppliers, if applicable
Requirement
Principal Relationships:
The Local Compliance Specialist reports into the Regional/Cluster/Country Compliance Lead as applicable or into the and is a member of the Compliance team.
Education and Experience Requirements:
A minimum of a bachelor’s degree in science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required. A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.
Related experience:
Knowledge of the overall drug development process
Developing or developed 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
Ability to motivate professional colleagues and stakeholders
Conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
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
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number “2406186213W”검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[ 제출 서류]
영문 자유 양식의 이력서/경력기술서/자기소개서
[ 서류 마감일]
채용시 마감
[ 유의사항]
국가보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.
입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.
제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.
www.careers.jnj.com
Qualifications
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Primary Location Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization Janssen Korea, Ltd. (7220)
Job Function Clinical Quality
Req ID: 2406186213W