Job Description

Job Summary This position is responsible for the overall support of preclinical/scientific research activities for the Company and supporting the execution of clinical research activities in APAC region. Position Responsibilities

• Coordinate preclinical/scientific research activities and assist respective project teams in the development of preclinical/scientific research for new product development projects.
• Coordinate administrative, logistics, inventory support for all preclinical/scientific studies, including pre-study set up, sample shipment, study protocol, implant/procedure, follow-up, explant/euthanasia and final reports.
• Perform duties in compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).
• Collaborate with external vendors on outsourced tasks and projects.
• Work in cooperation with Study Director, Principal Investigator, Interventionist, Pathologist, Project Manager and test facility research team closely to create project timelines and ensure that study deliverables are met.
• Monitor progression of preclinical/scientific studies to meet timeline, quality assurance and regulatory requirements.
• Review and follow up on timely completion of external study reports and communicate with related test facilities.
• Prepare and submit in-house test protocols/reports and correspondence in a timely, concise, and accurate manner.
• Maintain study records and ensure they are filed, archived and kept in an orderly manner.
• Manage preclinical financial payments to ensure total departmental and study costs as per target.
• Assist respective departments/teams to address regulatory queries and respond to any ad hoc requests.
• Provide preclinical/scientific inputs in preparation of non-clinical evaluation report as well as other technical documentation in accordance with applicable guidelines.
• Participate in preparation of Clinical Evaluation Report (CER) for new interventional devices in accordance with EU MDR, MEDDEV and other applicable guidelines as required.
• Support the execution of clinical research activities in APAC region and perform other assigned duties when required.

• Bachelor\'s Degree in Life Sciences/Biomedical Sciences/Biochemistry/Healthcare related fields or other scientific discipline or educational equivalent.
• Minimum of 5 years of relevant experience in MedTech/pharmaceutical industry or healthcare sectors.
• Experience working within GxP laboratories, contract research organization (CRO), research and development (R&D), or preclinical/scientific/clinical related research environment is preferred.
• Familiarity with the Principles of GLP and GCP or other applicable regulations, guidelines and international standards.
• Knowledge of experimental design (e.g. preclinical in vivo study), research methodology, statistical analyses, literature search, medical device and clinical terminology is desirable.
• Proficiency in medical/scientific writing will be advantageous.
• Excellent communication and problem-solving skills.
• Ability to work independently as well as a team, proactive, meticulous, quality-driven and timeline-driven.