Contract Medical Writer

Proclinical, in support of our client, are seeking an individual to fill the role of a Contract Medical Writer, based in North Carolina.

Responsibilities

• Develop clinical documents such as Clinical Trial Protocols (CTP), Informed Consent Forms (ICF), and Clinical Study Reports (CSRs).
• Develop documents for regulatory purposes such as IND, Investigator's Brochure, DSUR, PSUR, Briefing Books for health Authority interactions.
• Coordinate team contributions to the aforementioned documents. Schedule and lead initi­ation and adjudication meetings.
• Gather, evaluate, organize, manage and collate relevant information.
• Ensure compliance with regulations set by the regulatory authorities.
• Keep up to date with changes in regulatory legislation and guidelines.
• Ensure that quality standards are met.

Skills And Qualifications

• Relevant PhD or research-based MSc preferred, as well as 5+ years of pharmaceutical industry experience. 3-5 years' experience as a Regulatory or Medical Writer.
• Proficiency in Microsoft Office.
• Strong written, verbal, and interpersonal communication skills, as well as a command of written and spoken English.

To Apply:

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 contact George Watson at (+1) 929 223 4835 or upload your CV 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.

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