Contract Medical Writer - CSR exp required
Proclinical is currently recruiting for a Medical Writer for a vape and electronic cigarette company located in New York, NY. Successful candidate must be versed in Phase I - Pharmacokinetic Studies to write the Clinical Study Report (CSR) for one or more PK studies.
- Participate in training to become familiar with the study and protocols.
- Development of CSR Shell.
- Utilize Tables, Listings & Graphs (TLGs) populate CSR shell.
- Data interpretation and knowledge of high-quality statistical analysis.
Skills and Requirements:
- 10+ published CSRs.
- Experience working with nicotine, or inhalation studies (not necessary, but a plus).
- Experience with final study report writing.
- Experience writing CSR for PK studies (pharmacokinetic).
- PK experience is a must.
- Experience working as a medical writer in a pharmaceutical, biotech, freelance medical writer or CRO.
- Ability to provide 2 professional references and a work sample.
- In-depth familiarity & experience working with FDA Guidance's, GCPs and ICH guidelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4835 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.