Job details

Medical Writer

Job Summary and Primary Responsibilities

Our Medical Writer is key in generating medical writing deliverables in support of our research and scientific communication efforts in orthopaedic spine devices and related areas. Specialized in writing, editing, and reviewing regulatory documents, the Sr. Medical Writer supports and executes general medical writing activities. These activities include performing systematic literature reviews, as well as writing Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, and Summary of Safety and Clinical Performance (SSCP) reports in support of EU MDR compliance. This position will have direct interaction with key clients and opinion leaders in both content development and review functions. This position also supports marketing requirements with clinical/medical writing for public (journal, podium) dissemination on spinal disease and spine orthopedic devices/treatments.

Execute general medical writing, editing, and proofreading activities and systematic literature reviews for assigned CER projects
Develop CEPs, CERs, PMCF plans and evaluation reports, and SSCP reports in accordance to EU MDR requirements
Proactively communicate, as the primary liaison, with the project manager and other cross-functional teams, as applicable, to gather required information for assigned projects
Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines (e.g., MDD and MDR), and company templates
Be a key collaborator with the biostatistics and data management team for complete results interpretation and to ensure the delivery of accurate and relevant output
Demonstrate advanced problem-solving abilities
Achieve editorial excellence to produce clear, accurate, grammatically correct, and creatively written works for a variety of audiences
Demonstrate a high level of product and procedure knowledge to support research-related questions and independently provide internal/external training as necessary
Assist in developing and implementing corporate procedures for medical and regulatory writing
Assist research and other project team members in additional responsibilities as required
Performs other duties as assigned

Required Skills / Capabilities

Understanding of medical terminology
Strong understanding and comprehension of medical terminology and statistics
Excellent level proficiency with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems
Ability to accurately interpret data and present complex information in a clear and concise written manner
Solid written and verbal communication skills, analytical ability and problem-solving skills
Strong ability to multitask and work effectively in a fast-paced environment with changing priorities
Strong attention to detail and organizational skills

Education and Experience

Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
Bachelor’s degree in Life Science, Biological Science, or related discipline
2+ years of experience as a medical writer in a healthcare-related field/industry
Experience in a clinical or industry setting with study experience focused on spine, orthopedics, or medical devices preferred
Experience in writing regulatory reports, including CEPs/CERs and understanding of EU MDR requirements preferred

Travel and/or Physical Requirements

Remote work eligible

#LI-remote

Salary Range: $75,750- $126,250

For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here. NuVasive's EEO policy is available here.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.