Medical Writer/Senior Medical Writer

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
New Brunswick, New Jersey
Posting date: 19 Mar 2019
SC.GW.22303_1553006739

ProClinical, in support of our client, are seeking an individual to fill the role of Medical Writer/Senior Medical Writer, based in New Brunswick, NJ. The successful candidate will have a strong background in science, research and/or clinical work, and will want to develop cell therapy products for cancer treatment.

Responsibilities

  • Work with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, briefing books, and other relevant documents.
  • Contribute scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups.
  • Provide leadership in completing summary submission documents to support submission dossiers.
  • Ensure a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
  • Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.

Skills And Qualifications

  • MA/PhD in related field and 4+ years of relevant medical writing experience.
  • Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
  • Experience in oncology area preferred.
  • Solid knowledge and application of regulatory guidance documents.
  • Documented excellence in advanced features of Microsoft Word. Strong knowledge of a document management system.

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 call George Watson at (+1) 336-842-8682 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.

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