Clinical Scientist Intern

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)

Qualifications

Required Skills and Experience

University Hiring Program Eligibility Requirements: University Enrollment: Must be currently enrolled in and returning to an accredited degree-seeking academic program after the internship.

Internship Work Period

Must be available to work full-time (approximately 40 hours per week) during a 10-12 week period starting May or June. Specific start dates are shared during the recruiting process. Required Education and Training Current enrollment in a scientific field degree-seeking program at the Master’s, MD or Doctorate level. Working Conditions None

Preferred Skills and Experience

Some experience in an academic environment conducting literature searches, reviews and appraisal of scientific data. Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills. Excellent critical and analytical thinking skills. Must have a high level of attention to detail and accuracy. Must be able to work effectively across cross-functional teams.

Strong presentation and interpersonal skills. Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude) Consistently shows dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary