Medical Writer - Medical Devices
Job Title: Medical Writer
Department: Medical Operations
Reports To: Client direct Project Manager (Manager Medical Writing)
The Medical Writer plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) and Safety Surveillance Reports (SSR) for assigned therapeutic area and projects within the client’s Global R&D Medical Device sector.
POSITION DUTIES & RESPONSIBILITIES:
- Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area
- Prepares, writes, and edits crediable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices
- Participates in core process steps for systematic literature reivews including search, screen, data extraction, analysis, and synthesis of the literature for CER/SSR processes
- Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS)
- Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports.
- Organizes clinical data from literature into references, graphics, tables, and data listings
- Critically synthesizes clinical data being considered for presentation in the final report
- Performs scientific writing of the synthesized literature using templates
- Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and interpret statistical results of clinical studies
- Presents the results of sstematic literature reviews at internal meetings
- Collaborates with other Medical Operation Team members including Technical Specialists and Project Managers as applicable to gather information (timelines, projects, documents)
- Adheres to timeliness for systematic literature reviews within assigned project
- Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process to to identify the necessary clinical and technical information for assigned project
- Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study design, ensures compliance with medical device regulations globally, and escalates any new or emerging risks.
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
- Conducts scientific and medical writing and/or critically edits the deliverables (e.g. protocols and reports) from medical writing staff
EDUCATION & EXPERIENCE REQUIREMENTS:
- BA, BS, or BSN is required; advanced degree is preferred
- Minimum of 3years of related job experience
- Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required
- Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane) with demonstration in qualitative and quantitative synthesis in conjunction with scientific and medical writing
- Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse eventreporting is preferred
- Able to understand and interpret statistical results of clinical studies and understands good data management practices
- Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines
• Experience using software systems to manage literature data (e.g. Distiller)
- Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence
• Strong oral communication, presentation, project management and prioritization skills
• Excellent interpersonal relationships
- Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager)
Remunaration package and contract form:
This position comes with enhanced benefits which include:
• 50/50 shared healthcare cost (Company pays 50% of the monthly premium, employee pays 50%)*
• Paid holidays
• Paid sick days and vacation days*
Specifically: 10 Accrued PTO, 5 sick days, 9 JNJ facility holidays.
you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses
Weekly pay and service bonus plans*
Group- rate insurance options available immediately upon hire*
Let Company fuel your career—connect with us today.