Job Description

Overview

Cook Research Incorporated (CRI) is a dynamic company that is focused on improving patient care and is staffed with a diverse group of professionals, scientists, and technicians who have expertise in medical products. The highly talented and creative CRI team performs hundreds of in vivo and in vitro tests, manages regulatory submissions globally, and supports clinical studies from pre-market to post-market phases of product development.

CRI is currently accepting applications for a Scientific Communications Medical Reviewer to join our growing Scientific Communications/Clinical team. Medical Reviewers provide medical review of documents written by team members who do not have clinical experience.

This position is eligible to be hybrid or remote. This is a full-time opportunity with an expectation of work occurring within the conventional 9-to-5 Eastern Standard Time schedule (Monday through Friday).

Responsibilities

Provide medical review of clinical and certain regulatory documents (including Clinical Evaluation Plans and Clinical Evaluation Reports);

Assess clinical safety and performance data to ensure anatomic, physiologic and clinical accuracy and use the available data to assess the benefits and risks of device use; 

Understand and provide guidance on comprehensive, systematic searches of published medical literature;

Participate in the planning, development, and delivery of high-quality documents with a proactive approach to project management, including supervision of project timelines and communication of the process and timelines to stakeholders;

Participate in stakeholder meetings with cross-functional teams; 

Resolve document content issues and questions that arise from the writing/review process; 

Provide status updates on deliverables to management;

Understand medical writing and regulatory standards and practices; 

Proactively contribute to process improvements and knowledge sharing initiatives; 

Ensure consistency across and within documents; and 

Other duties as assigned (including the possibility of medical writing tasks).

Qualifications

MD or DO with medical device experience preferred; however, nurse practitioners and physician assistants may qualify, depending on training and experience;

Some amount of direct patient care experience is needed so that the candidate can appropriately assess device risks and benefits;

Candidate should be prepared to provide a list of procedures they have personally performed (e.g., tracheal intubation, central line placement, chest tube placement, etc.)

Candidate should be prepared to describe clinical decision-making for which they were personally responsible (e.g., providing orders for patients on an inpatient floor, emergency department, outpatient clinic, etc.)

Familiarity with literature search databases;

Familiarity with statistical methods, data analysis, and interpretation;

Ability to understand and interpret clinical/scientific data and to present results in an understandable and concise manner; 

Ability to work on multiple projects, organize, and prioritize within time constraints; 

Ability to work both independently and collaboratively in a cross-functional team environment;

Familiarity with Microsoft Office software (including basic keyboarding skills); 

Excellent written, verbal, and interpersonal communication skills with attention to detail (to detect inconsistencies or errors in various types of documents and communications); and 

Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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