Medical Writer

About the job

Join our team as a Medical Writer, where you will play a pivotal role in advancing clinical research and regulatory compliance within a dynamic biopharmaceutical environment. This role offers an exciting opportunity for a detail-oriented professional to contribute to the development of essential documentation that impacts public health and scientific understanding. If you are passionate about scientific writing, regulatory processes, and contributing to meaningful research.

Responsibilities:

• Develop clinical trial documents, e.g., clinical study protocols, investigators brochures, clinical study reports;
• Generate regulatory documents required for health regulatory agencies, e.g., Common Technical Document (mainly Modules 2.5 and 2.7) and prescription labelling;
• Develop scientific manuscripts and manage the paper publication process;
• Communicate with and respond to the comments from KOL, health regulatory agencies, and IRBS;
• Development, review, and maintenance of the SOPs relevant to medical research;
• Conduct scientific literature/medical guideline research;
• Assist clinical operation task if assigned.

Qualifications:

• PhD in the field of medical science, pharmaceutics, or biological science;
• More than 2 years of relevant work experience in clinical trials;
• Experience in the writing of clinical documents and scientific manuscript;
• Excellent English writing, presentation, and listening;
• Work well in both independent and team environment;
• Pay attention to detail.

Our company

PharmaEssentia Crop., ,,, ,

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.

• More detail : Company informationR&D pipeline