Job Description

You will play a critical role in supporting the Director of Scientific and other peers on the execution of clinical trials and bioequivalent studies for pharmaceutical, biotech, or combination products. You will help to provide oversight and management for all aspects of the development and execution of clinical trials/protocols, and execute Clinical Affairs functions in accordance with GCP guidelines, SOPs, and any other applicable regulatory requirements.

• Collaborate with other senior Clinical Affairs leadership and executive management to develop operating objectives, organizational structure, and staffing requirements.
• Ensure clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
• Implement techniques to improve productivity and maintain the most up-to-date practices.
• Direct the development of department orientation and other training programs as required.
• Manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

Leadership position with full clinical affairs and drug safety responsibility|Vast array of products from pharmaceutical to vaccines and medical devices

• BS/BA degree in science/health-related field, advanced degrees such as MS or PhD preferred.
• 5+ years of clinical trials and BE studies experience for biologics, oncology, pharmaceutical, medical devices
• Experience in working with and overseeing CROs and other external vendors is required.
• Experience developing clinical SOPs and plans.
• Excellent working knowledge of ICH GCP guidelines, ISO, MDD/MDR, and CFR regulations
• Able to work independently and make appropriate strategic decisions to operationalize and advance clinical trial activities
• Demonstrated strong and influential leadership skills with proven ability to lead internal and external team members at all levels. Demonstrated ability in growing clinical affairs teams from the ground up

My client is one of the largest integrated pharmaceutical Groups in Malaysia with a strong reputation as a provider of quality products and services from R&D to manufacturing of generic drugs, OTC medicines and nutraceuticals, fill and finish plant for vaccines.

• Work in an international, receptive and transparent corporate culture
• Join the team to make decisions to help improve people's lives over time
• Be rewarded with excellent, fair opportunities to grow personally and professionally