Full-time, Entry level
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 team. Medical Reviewers research and communicate clinical data relevant to Cook products and provide medical review of documents written by team members who do not have clinical experience. This position is eligible to be hybrid or remote.
Responsibilities
- Provide medical review of Clinical Evaluation Plans and Clinical Evaluation Reports (assess clinical safety and performance data to ensure anatomic, physiologic and clinical accuracy; assess the benefits and risks of device use);
- Guide the preparation of clear and comprehensive Clinical Evaluation Plans and Clinical Evaluation Reports;
- 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
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;
- 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.
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
I am a pharmacist, community pharmacy consultant, and medical writer with over 12 years of clinical practice experience in community, outpatient health system, long term care, and academic settings. I am also the founder of PharmCompliance.com, a website dedicated to the success of community pharmacy.
As a pharmacy project manager, I led the implementation of new service lines, assist with ensuring legal and third-party compliance for over 70 retail stores, lead quality improvement and medication safety initiatives, write policies, procedures, and best practices for all our retail sites, and help with optimizing revenue cycle and pharmacy profitability. I have been responsible for DMEPOS and vaccine accreditation through CMS, obtaining new licenses and permits, and implementing a prescription drug kiosk embedded in our physician offices.
As a medical writer, my work has been featured in GoodRx, Pharmacy Times, Drug Topics, Patient Care Online, and in peer-reviewed journals. I have also given presentations on a range of topics, from disease state pharmacotherapy for medical residents to updates on the CDC vaccine storage and handling guidelines for a medical-grade refrigerator and freezer manufacturer. I have written and presented continuing education for CEImpact, FreeCE, AchieveCE, Ascension Health, and the Florida Department of Health.
