- 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.
- 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.
To Qualify for this role,
You will have min 3-5 years of experience in Medical Tech/Pharmaceutical Industry or healthcare sectors.
Familiar with Principles of GLP and GCP , guidelines and international standards
Bachelor Degree in Life Science/Biomedical Science / BioChemistry or other related field of disciplines
Interested parties please click "Apply Now" or send your CV directly to Gina Ng (EA Reg no: R1110400) at firstname.lastname@example.org.
Peoplebank Singapore Pte Ltd, EA Licence Number: 08C5248.