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Regulatory Affairs jobs in Malásia

Study Coordinator - LCMS BioAnalytical

LABCORP DEVELOPMENT (ASIA) PTE. LTD.

Singapura
Presencial
SGD 45 000 - 65 000
Há 19 dias
Quero receber os alertas mais recentes de ofertas em Regulatory Affairs

Quality Manager @ Tuas

A & ONE PRECISION ENGINEERING PTE. LTD.

Singapura
Presencial
SGD 70 000 - 90 000
Há 19 dias

Accounts Manager: Lead Closings, AR/AP & Insights

FCS Careers

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias

Valet Driver

Marina Bay Sands

Singapura
Presencial
SGD 20 000 - 60 000
Há 19 dias

Supplier Quality Engineer

Flex

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias
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Tipper Truck Driver

MAJESTIC CIVIL ENGINEERING

Singapura
Presencial
SGD 30 000 - 40 000
Há 19 dias

Lab Technologist #HAC

RECRUIT EXPRESS PTE LTD

Singapura
Presencial
SGD 30 000 - 40 000
Há 19 dias

Preschool Principal

JOBS IN RECRUITMENT CONSULTANCY PTE. LTD.

Singapura
Presencial
SGD 125 000 - 150 000
Há 19 dias
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Marketing and Trading Manager - LNG

INPEX ENERGY TRADING SINGAPORE PTE. LTD.

Singapura
Presencial
SGD 120 000 - 160 000
Há 19 dias

Japanese Speaking Senior Business Development and Market Research Professional

GLOBAL ANGLE PTE. LTD.

Singapura
Presencial
SGD 70 000 - 90 000
Há 19 dias

Senior Legal Counsel (Data Privacy)

WECHAT INTERNATIONAL PTE. LTD.

Singapura
Presencial
SGD 70 000 - 100 000
Há 19 dias

Senior Food Scientist, Master Yogurt Formulation

Ingredion

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias

Advisory Solution Consultant, Security

MPC Moving Picture Company

Singapura
Híbrido
SGD 70 000 - 100 000
Há 19 dias

Junior Quantity Surveyor: Renovation Costing & Feasibility

Talent Trader Group Pte Ltd

Singapura
Presencial
SGD 30 000 - 45 000
Há 19 dias

Senior Quantity Surveyor - Lead Estimating & Contracts

Yuan Mei Chen

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias

Finance Manager

NexusHire Solutions

Singapura
Presencial
SGD 80 000 - 120 000
Há 19 dias

Junior Quantity Surveyor (Contract based)

Talent Trader Group Pte Ltd

Singapura
Presencial
SGD 30 000 - 45 000
Há 19 dias

Clinical Research Coordinator (West/ Central/ Entry Level) #HZO

RECRUIT EXPRESS PTE LTD

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias

Lead Process Engineer / Senior Process Engineer (CQV Process Equipment)

Advanced Manufacturing Tech Solutions (AMTSOL)

Singapura
Presencial
SGD 70 000 - 90 000
Há 19 dias

Pre-sales Engineer, Credit & Risk Solutions

OSTTRA

Singapura
Presencial
SGD 70 000 - 90 000
Há 19 dias

Citigold Client Advisor (North Asia)

15574 CITIBANK SINGAPORE LTD USDFCY

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias

Facultative Reinsurance Team Leader (1-year contract)

Marsh McLennan Companies

Singapura
Presencial
SGD 100 000 - 150 000
Há 19 dias

Assistant Vice President, Operations Manager (NFRR), Global Operations

BANK OF AMERICA,NATIONAL ASSOCIATION

Singapura
Presencial
SGD 100 000 - 150 000
Há 19 dias

STUDENT CARE CENTRE MANAGER (TAMPINES)

SELF HELP GROUPS STUDENT CARE LIMITED

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias

Operations Manager / Asst Ops Manager [Mon–Fri + Sat Half Day | Jurong West | ≤ $4,000] – EH03

The Supreme HR Advisory

Singapura
Presencial
SGD 60 000 - 80 000
Há 19 dias
Study Coordinator - LCMS BioAnalytical
LABCORP DEVELOPMENT (ASIA) PTE. LTD.
Singapura
Presencial
SGD 45.000 - 65.000
Tempo integral
Há 19 dias

Resumo da oferta

A leading laboratory services company in Singapore seeks a candidate to manage study protocols, draft reports, and ensure compliance with regulations. The ideal candidate should have a BS/BA degree and 2-4 years of related experience. Strong project management and communication skills are essential. This role emphasizes detail and independent project tracking in a dynamic environment.

Qualificações

  • Minimum of 2-4 years working experience in related fields.
  • Experience may be substituted for education.
  • Proven ability to manage increasingly complex projects.

Responsabilidades

  • Draft protocols, sample analysis outlines, and study schedules.
  • Review study compliance against protocol and regulations.
  • Prepare reports and maintain organized study files.

Conhecimentos

Concise writing
Attention to detail
Project management
Communication skills
Use of word processing software

Formação académica

Bachelor of Science/Arts (BS/BA)

Ferramentas

Word processing software
Database software
Spreadsheet software
Descrição da oferta de emprego

Job Level & compensation offered may vary depending on candidates’ experiences and competencies.

Responsibilities / Duties
  • Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
  • Reviews study compliance against protocol, SOP and regulatory agency guidelines.
  • Communicates and interacts with study team, other departments and clients as applicable.
  • Assists in the development and maintenance of standard report/table formats as needed.
  • Plans, prioritizes and manages own workload and multiple responsibilities.
  • Independently use project tracking systems as appropriate.
  • Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
  • Participates in and assists Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
  • Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
  • Assists in interpreting and evaluating data for reports.
  • Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
  • Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
  • Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
  • Responsible for report production processes through finalization, including archival of data as appropriate.
  • Assists SD/PI in monitoring study progress.
  • Schedules study phases in coordination with SD/PI and lab operations.
  • Perform quality control review of data.
  • With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.
  • Provides input and participates in project meetings, plans, monitors and guides project work.
  • Trains, mentors, and assists less experienced staff.
  • Participates in client visits as needed, assists in communicating technical information.
  • Participates in process improvement initiatives.
  • Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
  • Assists in writing reports and protocols.
  • Writes SOPs and methods.
  • Maintains an awareness of the financial status of ongoing studies
  • Serve as the primary contact in communication and interaction with other departments and clients as applicable.
  • Serves as a backup PI/SD on project management tasks.
  • Performs other related duties as assigned.
Requirements
  • Minimum Bachelor of Science/Arts (BS/BA) degree with 2-4 years working experience
  • At least two years related or relevant experience.
  • Experience may be substituted for education.
  • Efficient use of word processing software, database, spreadsheet and specialized software
  • Proficient in concise writing. Writing should require little or no external review or edit.
  • Adherence to grammar, punctuation, composition and spelling accordingly to company standard conventions.
  • Experience on a variety of studies performed in the department and exposure to a diverse client base.
  • Knowledge of regulatory agency guidance.
  • Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
  • Proven ability to manage increasingly complex projects and study designs and/or increased study load.
  • Demonstrated capability to manage work for key clients.
  • Demonstrated ability to support and be involved in process improvement initiates and endeavors
  • Proven ability to plan, prioritize and manage workload and multiple responsibilities.
  • Demonstrated ability to independently use project tracking systems as appropriate.
  • Excellent communication, presentation and interpersonal skill.
  • Excellent attention to detail
  • Efficient in prioritizing and managing time.
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* O salário de referência é obtido com base em objetivos de salário para líderes de mercado de cada segmento de setor. Serve como orientação para ajudar os utilizadores Premium na avaliação de ofertas de emprego e na negociação de salários. O salário de referência não é indicado diretamente pela empresa e pode ser significativamente superior ou inferior.

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