About the job
PharmaEssentia Corp, is a Taiwan-based, full-spectrum biopharmaceutical company specializing in the innovation, clinical development, manufacturing, and global marketing of new drugs. Leveraging its deep expertise and core R&D capabilities, PharmaEssentia is committed to providing advanced treatment options in hematology and oncology, with self-developed product currently on the market and a continually expanding product portfolio.
We are seeking a highly experienced and motivated Global Project Manager to lead biopharmaceutical clinical trials from a sponsor's perspective. This role is responsible for strategic planning and execution across global clinical projects, ensuring high-quality and timely study conduction.
Responsibilities:
- Serves as global level project manager from sponsor end (perform and participate in project development process and CRO and vendors selection, review core document/procedure, etc.)
- Meet country goals through project strategy planning/execution in collaboration with project members.
- Ensure study conduction with speedy and good quality through project leadership with internal cross functional teams, CRO Oversight, Issue management, CRO oversight monitoring visit and etc.
- Initiates and maintains relationships with Investigator according to assigned therapeutic area.
- Support and lead country activity to enhance cross-functional department cooperation according to assignments.
- Perform other duties as assigned.
Qualification
- Minimum of 15 years of experience clinical trial, with specific experience in project management, audit readiness and regulatory submissions for biologics products.
- Global Clinical Trial experience
- Strong knowledge of GCP regulations and guidelines, including FDA and ICH requirements.
- Experience with IND submissions and regulatory interactions with FDA or other regulatory agencies.
- Strong analytical and problem-solving skills, with the ability to identify compliance issues and propose effective solutions.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Ability to work independently and prioritize tasks in a fast-paced environment.