[근무회사 및 모집부문]
* 근무회사: 명동역에 위치한 글로벌 헬스케어 솔루션 기업
* 사업분야: 임상시험 수행(CRO), 헬스케어 데이터 분석 및 리얼월드 데이터(RWD), 임상시험 모니터링 및 규제 대응 지원
* 모집부서: RA
* Position Title: RA Officer
[회사 소개]
본 회사는 헬스케어 데이터, 첨단 분석, 기술 솔루션 및 임상 연구 서비스를 제공하는 글로벌 헬스케어 기업으로, 전 세계 제약·바이오 기업이 신약을 보다 빠르고 효율적으로 개발하고, 환자에게 전달할 수 있도록 지원하고 있습니다.
방대한 리얼월드 데이터(Real World Data)와 과학적 분석 역량, 글로벌 임상 수행 경험을 기반으로
고객사의 연구개발(R&D)부터 상업화 전반에 걸친 의사결정을 지원하고 있습니다.
[업무내용]
- Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
- Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls /Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
- Understands the Scope of Work, deliverables for any given project;
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
- May prepare and deliver trainings, as appropriate;
- Performs other tasks or assignments, as delegated by Regulatory management;
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;
[지원자격]
• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• Master's Degree Degree in Lifescience or related discipline Req
• At least 1 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
[전형절차]
- 서류심사 > 1차 면접 > 합격
* 절차의 경우 업체 상황에 따른 변동이 있을 수 있습니다.
[근무환경]
- 고용형태: 맨파워소속 파견계약직
- 계약기간: 6개월 (육아휴직대체)
- 근무지: 명동역 인근 오피스 (거주지에 따라 근무지 조정 가능 / 재택 주 4일 병행)
- 근무시간: 09:00 ~ 18:00 (주 5일 근무)
- 급여: 회사 내규에 따름
- 복리후생: 4대보험, 연차, 연차수당, 제휴 호텔 할인, 화상영어 제휴 할인, 생일/명절 선물, 경조 휴가/경조금, 우수사원 시상, 주 4일 재택근무 등
[지원방법]
- 홈페이지 지원
- 이메일 지원: joy.park@manpower.co.kr
- 담당자: 박윤주 02-6677-9925
- 제출서류: 국/영문 이력서 및 자기소개서 MS-Word 양식
** 서류전형 합격자에 한해 개별 연락 드립니다.
** 서류 접수순으로 수시 면접 진행하고 있으며, 합격자 발생 시 공고가 마감되기에 빠른 지원 결정 부탁드립니다.