[PPD] 피피디, Principal Regulatory Specialist 모집 공고

CRO
RA
admin_ju
2020-06-29 18:38
조회수
38
출처 : 신약 개발임상 연구원

PPD Korea 에서는 아래 포지션에 대해서 지원자를 모집하고 있습니다.

관심 있는 분들의 많은 지원 바랍니다.

지원방법 : 영문이력서(CV) email 발송 Dinesh Reddy <Dinesh.Reddy@ppdi.com>

We are vital linksbetween an idea for a new medicine and the people who need it. We are thepeople of PPD — thousands of employees in locations worldwide connected bytenacity and passion for our purpose: to improve health. You will be joining atruly collaborative and winning culture as we strive to bend the time and costcurve of delivering life-saving therapies to patients.   

 

At PPD wehire the best, develop ourselves and each other, and recognize the power ofbeing one team. We offer continued career advancement opportunities, awardwinning training and benefits focused on the health and wellbeing of ouremployees. 

If you’re a strategicthinker, planner and multitasker as comfortable working independently as youare on a team in delivering compliant deliverables based on solid judgment, PPDis the place to be. Our global regulatory experts contribute the regulatorystrategy and knowledge to help our clients navigate the challenging regulatoryenvironment — and help get life-changing therapies to patients faster. 

As a PrincipalRegulatory Affairs Specialist, you will provide innovative regulatory solutionsto our clients. 

 

SummarizedPurpose:   

Serves as thelead over several countries/projects in providing innovative solutionsincluding regulatory expertise and client interface to provide strategicregulatory intelligence, and guidance supporting product development frompreclinical through registration and product optimization. Provides strategic,expedient and efficient preparation of client deliverables that meet currentlocal, regional and ICH regulatory and technical requirements. Acts as liaisonwith internal and external clients in the provision and marketing of theseservices. 

 

EssentialFunctions:   

  • Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements. 
  • Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. 
  • Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services. 
  • Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables. 
  • May provide input on performance reviews to management. 
  • Ensures adherence to project budgets, time schedules, and scope of work. 
  • Ensures compliance with relevant organizational and regulatory SOPs and WPDs. 
  • Contributes to business development activities, including project budgeting/forecasting. 

 

Educationand Experience:   

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification  
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 

Knowledge, Skills andAbilities:   

  • Excellent English language (written and oral) communication skills as well as local language where applicable 
  • Great attention to detail and quality as well as excellent editorial/proofreading skills 
  • Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments 
  • Strong computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies 
  • Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects 
  • Strong negotiation skills 
  • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables 
  • Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc. 
  • Strong understanding of medical terminology, statistical concepts, and guidelines 
  • Excellent analytical, investigative and problem-solving skills 
  • Solid understanding of budgeting and forecasting 

WorkingEnvironment:  

  • PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 
  • Able to work upright and stationary for typical working hours.  
  • Ability to use and learn standard office equipment and technology with proficiency. 
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.  
  • May require travel.  (Recruiter will provide more details.)  

 

PPDDefining Principles: 

- Wehave a strong will to win

- We earn our customer’s trust

- We are game changers

- We do the right thing

-We are one PPD - 

If youresonate with our five principles above, and ultimately wish to accelerate thedelivery of safe and effective therapeutics for some of the world’s most urgenthealth needs, then please submit your application – we’d love to hear fromyou. 

Interested applicants are encouraged to send their English CVs/Resume to Dinesh Reddy <Dinesh.Reddy@ppdi.com>

전체 0

전체 809
NO. 제목 작성자 좋아요 조회수 작성일
공지사항
채용공고 게시판 포인트 공지사항
Admin_ms | 2020.04.22 | 추천 0 | 조회 472
Admin_ms 0 472 2020.04.22
공지사항
임금 체불사업주 명단 공지
Admin | 2019.10.26 | 추천 1 | 조회 1729
Admin 1 1729 2019.10.26
807
[ICON DOCS] We are hiring multiple positions!
N
admin_ju | 조회 9 2020.07.14 | 추천 0 |
admin_ju 0 9 2020.07.14
806
[LSK Global PS] 경력 CRA 채용
N
admin_ju | 조회 8 2020.07.14 | 추천 0 |
admin_ju 0 8 2020.07.14
805
(주)드림씨아이에스 RBM(Risk Based Monitoring)담당자 채용
N
admin_ju | 조회 8 2020.07.14 | 추천 0 |
admin_ju 0 8 2020.07.14
804
[씨엔알리서치] LPS팀 PM 채용
N
admin_ju | 조회 6 2020.07.14 | 추천 0 |
admin_ju 0 6 2020.07.14
803
[씨엔알리서치] LPS팀 CRA 채용
N
admin_ju | 조회 7 2020.07.14 | 추천 0 |
admin_ju 0 7 2020.07.14
802
[씨엔알리서치] CO팀 경력 CRA 채용
N
admin_ju | 조회 5 2020.07.14 | 추천 0 |
admin_ju 0 5 2020.07.14
801
(주)드림씨아이에스 CRS 채용(1년 계약직)
N
admin_ju | 조회 2 2020.07.14 | 추천 0 |
admin_ju 0 2 2020.07.14
800
[Parexel] CRA, PL, RA 채용
N
admin_ju | 조회 5 2020.07.14 | 추천 0 |
admin_ju 0 5 2020.07.14
799
[씨젠] 2020년 하반기 채용 (임상)(~2020.07.31)
N
admin_ju | 조회 5 2020.07.14 | 추천 0 |
admin_ju 0 5 2020.07.14
798
[시믹코리아] PM 경력 모집
N
admin_ju | 조회 3 2020.07.14 | 추천 0 |
admin_ju 0 3 2020.07.14
797
[시믹코리아] CRA(I, II, Sr.) 채용
N
admin_ju | 조회 3 2020.07.14 | 추천 0 |
admin_ju 0 3 2020.07.14
796
[시믹코리아] Senior Medical Writer 채용
N
admin_ju | 조회 3 2020.07.14 | 추천 0 |
admin_ju 0 3 2020.07.14
795
[시믹코리아] Medical Writing Leader 채용
N
admin_ju | 조회 2 2020.07.14 | 추천 0 |
admin_ju 0 2 2020.07.14
794
[PSI CRO Korea] CRA II
N
admin_ju | 조회 3 2020.07.14 | 추천 0 |
admin_ju 0 3 2020.07.14
793
[PSI CRO Korea] Regulatory Officer
N
admin_ju | 조회 2 2020.07.14 | 추천 0 |
admin_ju 0 2 2020.07.14
792
[PPD Korea]Study Start-up team, Sr. CAS 모집
N
admin_ju | 조회 3 2020.07.14 | 추천 0 |
admin_ju 0 3 2020.07.14
791
[한국 노바티스_Project Leader_Oncology BU]
N
neferti | 조회 32 2020.07.14 | 추천 0 |
neferti 0 32 2020.07.14
790
[한스바이오메드] 2020년 7월 수시채용(CRA/마케팅)
admin_ju | 조회 33 2020.07.13 | 추천 0 |
admin_ju 0 33 2020.07.13
789
(주)파마크로(PharmaCRO)신입/경력 DM팀 DBA 모집
admin_ju | 조회 44 2020.07.10 | 추천 0 |
admin_ju 0 44 2020.07.10
788
(한일병원) 임상연구심사위원회 행정간사 모집
admin_ju | 조회 24 2020.07.10 | 추천 0 |
admin_ju 0 24 2020.07.10