- Lead writer independently responsible for the preparation of clinical study protocols and clinical study reports (CSRs), and other documents as needed for lower complexity studies.
- Provides support to more experienced writers with the preparation of clinical study protocols and CSRs, and other clinical documents as needed. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate.
- Responsible for preparation and review of clinical documents such as patient safety narratives and CSR appendices.
- Ensure timely delivery of high quality documents to internal customers and Sponsors.
- Provision of training for Associate Medical Writers and other staff as appropriate.
- Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred
- Typically minimum 1 years medical writing experience or 2 years professionally-related experience
- Excellent command of written and spoken English
- Good written and verbal communication skills
- In-depth knowledge of MS Word
- Good organizational and time management ability
- Excellent interpersonal skills
- Scientific or Clinical research experience desirable
- Good scientific writing skills.
- Understanding of medical, pharmacokinetic and statistical principles.
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