Oncogen Pharma (Malaysia) Sdn Bhd Vacancies Senior Executive, Clinical Affairs

Oncogen Pharma (Malaysia) Sdn Bhd is looking for new potential candidates to fill in for Senior Executive, Clinical Affairs position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.

Job Description

Responsibilities :-
  • To prepare, organize, manage as well as monitoring bioequivalence (BE) study/ clinical trials in-accordance with the ICH E6 GCP and any other applicable local SOP/GCP's.
  • To plan, initiate and executing BE study/ clinical trial within allocated resources, budget and timeline. 
  • To develop, compile and review all study-related regulatory and administrative documents from investigational sites, study protocol, monitoring visit reports and other study related documents. 
  • To liase with Contract Research Organization (CRO) on all projects from start-up until receipt of final report.
  • To perform monitoring aspects of BE study/ clinical trial as stated in ICH E6 GCP, local GCP's as and when required (lest than five (5) times per year)
  • To manage and handling of investigational products.
Requirements :-
  • Possessed minimum of Bachelor Degree in Pharmacy/ Pharmacology or Bio Medical or equivalent. 
  • Certified in 'Good Clinical Practise (GCP)' course.
  • Preferably candidate with a minimum of two (2) years of working experience in clinical research (pharmaceutical/ CRO industry) or monitor in BE/Clinical studies.
  • Effective written and verbal communication skills as well as good command in English.
  • Excellent in Microsoft Office applications (e.g. Word, Excel, Powerpoint)
  • Good understanding in cross-functional processes, BE study/clinical trial processes. 
*Only shortlisted candidate will be contacted by our recruiter. 

Company Overview

Oncogen Pharma is a fully integrated research based pharmaceutical company with a global outlook to cancer treatment. Based in Malaysia, it is one of the fastest growing Pharmaceutical company in the country with the largest portfolio of Oncology products under development. Oncogen Pharma has established the most advanced R&D facilities for developing Oncology APIs and formulations for regulated markets. The diversified and qualified technical team of top professionals from different parts of the world have deep experience & exposure of the development of strategic products for global markets.
Oncogen's API and Formulation plants are set-up close to each other on over 8 acres of land in Enstek Park, Malaysia & are designed by international experts following stringent regulatory requirements by authorities across the globe including USFDA, EMA, PIC/S and WHO. These containment by Design (CbD) facility will have capabilities to develop Solid oral as well as Injectable products for regulated & key emerging markets. They can handle multiple potent products at a time which belong to OEB 4 and 5 categories in full containment fashion addressing needs of safety of product, person & environment. These facility are the first QbD based designed high containment facilities with latest technology and advanced machiniries sourced from top-rated manufacturers from across the world.

How To Apply

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