Principal Medical Writer
Principal Medical Writer
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Parexel is in the business of improving the worlds 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 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
Required Experience:
Staff IC
Employment Type
Full-Time
