핵심 정보
- 경력
- 경력 4년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직 수습기간 3개월
- 우대사항
-
- 외국어 능력영어능통자
- 활동/경험해당직무 근무경험
- 급여
- 면접 후 결정
- 근무지역
- 서울 용산구
본 채용정보는 마감되었습니다.
(주)한국얀센에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
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/.
1. 포지션: Local Compliance Specialist
2. 계열사: 얀센 (Janssen)
3. 근무지: 서울시 용산구
4. 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
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
기업정보
이 기업의 다른 공고 (6건)
이어보는 Ai매치 채용정보
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.