Principal Medical Writer
Poland, Remote 职位编号 R0000033394 类别 Medical Writing关于这个职位
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
We are currently recruiting a Principal Medical Writer based in Poland, who will work as part of the Drug Safety writing team.
The Senior Medical Writer is responsible for comprehensive signal management, including detection, analysis, and evaluation from various sources. They oversee the end-to-end signal management process, collaborate with client safety science , and adhere to client-defined plans and SOPs. The PMW also contributes to preparing, updating, and managing various safety documents including Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate reports. This position requires expertise in pharmacovigilance processes and the ability to manage complex safety data.
This role also focuses on training junior staff, and requires strong communication, and problem-solving skills, balancing mentoring and client relation and requires expertise in pharmacovigilance, strong analytical skills, and the ability to collaborate across functions to ensure comprehensive product safety management across multiple therapeutic areas.
Knowledge and Experience:
- Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
- Good knowledge of medical terminologies
Education:
- Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
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