1. 모집부문: Medical Writing Leader

• 담당 업무:

- Responsible as Functional Manager, to work collaboratively with other operational project team to ensure seamless cross-functional communication/documentation and that the project related activities are conducted in the highest quality standards, in compliance with ICH E6/ local GCP and applicable local regulatory requirements as well as to meet/exceed sponsor’s expectation.

- Write and edit clinical documents and submission to the sponsor

-Prepare protocols, clinical study reports,integrated summaries, all types of regulatory-agency submissions and medical writing as required

- Analysis and interpretation of clinical trial data in medical points of view

- Ensure quality of the documents & manage the document review process

- Ensure there is appropriate compliance with GCP, SOPs, guidelines and regulatory requirements

- Ensure compilation of appendices to trial reports

- Participate in project team meetings to provide input regarding deliverable,timelines, and processes

- Conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients

- Performs other duties as requested by management

-Support in review/revision/development of medical writing related SOPs., work guides etc

-Support Company’s operation by assisting/coordinating and conducting orientation and applicable training for new employees as required

-Coordinate and support/Assist in site and CRO Audit or inspection as required

• 자격 요건: 

- 유관 경력 5~6년 

- Qualified candidates must have experience writing protocols and protocol amendments, clinical study reports, investigator brochures, and all types of regulatory agency submissions

- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature 

2. 전형

- 서류 및 면접 전형 (*합격자에 한하여 개별 연락)

3. 지원방법 및 문의사항

- 경력소개 중심의 이력서 및 간단한 자기소개서 첨부 (*영문 필수)

- 이메일 제출: ck_recruit@cmicgroup.com

4. 복리후생

-  4대보험 가입, 퇴직금 별도, 탄력근무제, 법인휴대폰 지급, Family week, 창립기념일 휴무 등

[CMIC KOREA]

CMIC Group was established as the first CRO in Asia in 1985. We offer greatly expanded services that encompass an entire value-chain of pharmaceutical companies, including manufacturing, sales, and marketing, based on our unique “Pharmaceutical Value Creator(PVC)” business model. CMIC Korea is the first CRO launched in Korea as well in 1996 and has supported drug development of pharmaceutical companies with expertize and quality for the last 23 years in Korea.

시믹그룹은 1985년에 아시아 최초로 설립된 CRO(Clinical Research Organization)이며 일본에 본사를 두고, Pharmaceutical Value Creator라는 Business Model로 CRO서비스 뿐만 아니라 의약품 개발, 생산, 영업 등 포괄적인 서비스를 제공하며 전세계적으로 서비스 영역을 확장하고 있습니다.시믹코리아는 1996년도에 한국에 최초로 설립된 CRO로서, 23년간 다양한 Therapeutic Area 에서 임상경험을 축적해 왔습니다. 우수한 인재 양성 프로그램, 체계적인 SOP와 Quality Management System을 기반으로 Clinical Operation, Project Management, Regulatory Affairs, Data Management, Statistical Analysis, Medical Writing등, 임상시험에 필요한 모든 서비스를 제공하는 Full Functional Service Provider로 활약하고 있으며, 국내임상시험, 다국가 임상시험, Early phase와 Late Phase 임상시험을 균형 있게 진행하고 있습니다. 

Pharmaceutical Value Creator로서 아시아를 넘어 세계로 성장하는 시믹코리아와 함께 하실 역량있는 인재 여러분을 모집합니다.

[출처] [시믹코리아] Medical Writing Leader 채용 (신약 개발임상 연구원 모임) |작성자 CMIC HR