Clinical Scientist Intern

Beschreibung:

Job Description

Primary Function of Position
This position reports to the Sr. Manager, Medical Sciences, and requires a candidate with a strong interest in medical writing of clinical and regulatory documents. This position will focus on medical literature review, clinical data summary, and the development of certain sections of Clinical Evaluation Reports in support of the EU CE Mark application. This role may also support the clinical review of US marketing materials.
Essential Job Duties
This position has responsibility and authority for the following:
* Review and contribute to authoring clinical documentation, mainly the Clinical Evaluation Reports (CER), including the clinical section of other regulatory documents.
* Learn about therapeutic areas.
* Contribute to the critical review of clinical content in promotional material.
* May assist with the development of clinical literature reports or other clinical documents such as protocols, clinical study reports, conference abstracts, and peer-reviewed publications.
* Have a basic understanding of the literature review processes.
* Participates in and/or performs comprehensive literature searches to develop knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
* Work with the clinical librarian to help with conducting literature searches on products/product families.
* Critically appraise scientific literature and write clinical summaries for products and surgical procedures.
* Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities.
* Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)