For one of our big pharma clients in Tel Aviv we are looking for a Medical Writer, in Global Medical Writing, provides medical writing to support Clinical Research and Development (and other departments as appropriate) in the production of clinical research documentation in support of drug development, product registrations, and product marketing.
- Annual Reports for the FDA
- Creates written reports which include risk analysis for new products / line extensions submitted for approval to US, European, Canadian, Australian, Chinese, and Japanese or elsewhere.
- Executes literature search and enhanced post market surveillance strategies for Safety Surveillance Plans (SSP) / Post Market Surveillance Plans (PMSP) / Safety Surveillance Reports (SSR)
- Risk assessment for assigned therapeutic areas
- Clinical Justifications and Rationale due diligence for additional indications
- Evaluation of offlabel data for new possible indications
- Ongoing reviews and literature synthesis of existing data on diseases/treatments specific to assigned therapeutic area.
- R&D support (e.g., identifying performance measures) as needed
- Competitor product analysis for value analysis briefs, white papers and meeting abstracts.
- Ad Hoc Literature searches/synthesis requests to supporting departments
- Weekly literature review cross functional alerts for any new important publications focusing on diseases or therapy areas assigned
- PhD in the Life Sciences (or other related field)
- Drug Development Experience
- Clinical Pharmacology Experience
- Narrative writing experience is a plus
- Minimum of 3 years experience in Medical Writing
- Excellent written and spoken English
- General Comments
POTENTIAL OPPORTUNITY for medical writers in ISRAEL