Senior Medical Writer

Proclinical, in support of our client, are seeking an individual to fill the role of Senior Medical Writer, based in Massachusetts. The successful candidate will work in collaboration with the cross functional teams to ensure that clinical documents accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements.

Responsibilities

• Write and edit documents relevant internal and external documents.
• Accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements.
• Write internal and external documents to ensure the delivery of high-quality documents that are scientifically rigorous, logically organized, and provide accurate data presentation and interpretation.
• Ensure final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the international conference on harmonization (ICH).
• Develop strategy for organizing and preparing clinical documents for regulatory health authority submissions.
• Perform quality control review of medical writing documents.
• Assist in the development of templates, style guidelines and SOPs for clinical documentation.

Skills And Qualifications

• Advanced Scientific Degree required - BA considered with appropriate work experience.
• 2-6 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment.

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) 929-223-4385 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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