NuVasive is seeking a Clinical Resources Specialist to support the mission of Clinical Resources to produce timely and appropriate scientific publications and to provide assistance to external customers, Sales, Marketing/Development, and Regulatory by searching for, reviewing, analyzing, summarizing, and delivering clinical information in a variety of forms. Creative, energetic, and resourceful self-learners interested in working with a highly motivated team of researchers dedicated to providing high-quality written materials with cheetah speed are encouraged to apply.
Summary: Will serve as a member of the Clinical Resources team and perform post-market clinical research in support of the mission of Clinical Resources. This includes the production of timely and appropriate scientific publications based on the collection, analysis, interpretation, and write up of post-market research projects. In addition, this role will provide assistance to external customers, Sales, Marketing/Development, and Regulatory by searching, reviewing, analyzing, summarizing, and delivering clinical information in a variety of forms.
Essential duties and responsibilities include the following. Other duties may be assigned.
- Search for, critically appraise, and summarize scientific and medical literature relevant to spine surgery. This involves using scientific search engines to identify relevant literature, reading and understanding of the literature, using independent judgment to determine the relevant information from articles found, and ability to concisely summarize the findings with few errors in a written format. Documents to be created/updated/reformatted as part of this job function include scientific manuscripts, abstracts, white papers, internal regulatory documents, presentations, marketing documents, and other materials.
- Collect, organize, analyze, interpret, summarize, and contextualize results of research data from a variety of sources for use in manuscripts, white papers, and presentations.
- Maintain NuVasive’s shared and internal scientific library resources (electronic and physical).
- Administer internal and external requests for medical information in compliance with the NuVasive policy for requests of off-label medical information. This entails providing materials (literature or summaries) following FDA and NuVasive guidelines for distribution of clinical literature.
- Assist research and other project team members in additional responsibilities as required.
Perform duties in compliance with applicable regulations and standards such as FDA Quality System Regulation and ISO (International Organization for Standardization)
Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience/Skills: Bachelor’s degree (B.S.) from Four‑year College or university required. Knowledge of PubMed search strategies, understanding of medical writing style and referencing (AMA standard) and understanding of medical research methodology, study design, and statistical concepts. At least 2 years of experience in a pre- or post-market research role required. A working knowledge of spine, the spinal implant market, minimally invasive products, and surgical spine techniques a plus.
Computer Skills: Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), charting, flow charting, and graphs. Experience with data management and analysis using Excel required; experience and proficiency using statistical software (SPSS, SAS/JMP) preferred. Competency in navigating the Internet. Experience with scientific search sites (PubMed) and strategies.
Language Skills: Competent in written and spoken English. Documented medical writing or scientific writing required. Ability to read and interpret documents such as safety rules, company policy, and procedure manuals. Strong ability to communicate technical information clearly and concisely in verbal, written, and graphical formats. Ability to speak effectively before groups of customers, employees, and management of organization.
Mathematical Skills: Statistical analysis understanding and ability is required. Candidate must be comfortable reporting and interpreting data using summary and comparative statistics. Must be able to apply the correct statistical tests to clinical data.
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and/or concrete variables. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to walk and reach with hands and arms.
The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Education and/or Experience/Skills: Bachelor’s degree (B.S.) from Four‑year College or university required. Knowledge of PubMed search strategies, understanding of medical writing style and referencing (AMA standard) and basic understanding of medical research methodology, study design, and statistical concepts. A working knowledge of spine, the spinal implant market, minimally invasive products, and surgical spine techniques a plus.
Job Location San Diego, California, United States
Position Type Full-Time/Regular