Medical Writers (CER) - Remote job Fort Washington Pennsylvania
Medical Writers (CER) - Remote job Fort Washington Pennsylvania
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Medical Writers (CER) - Remote Job



Employer Name: SpiderID: 8645591
Location: Fort Washington, Pennsylvania Date Posted: 5/13/2019
Wage: Up to $0.00 per year Category: Medical/Health
Job Code: 355170

Job Description:


Our client has an exciting opportunity for a Medical Writer. This position can work remotely.



The Medical Writer plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects within R&D Medical Device sector. The high-level activities may include:
Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area
Prepares, writes, and edits creditable 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 reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER 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 systematic 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 process 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
REQUIRED QUALIFICATIONS:
M.D. or PhD educational level (Pharmacy/Life Sciences)
Strong knowledge of Clinical and Scientific Research Methodology
Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety)
Excellent communication skills (writing and verbal) in English
Work experience in R&D/Drug Development and/or Device Development in Pharmaceutical and/or Medical Device companies
Has published, peer-reviewed studies/literature in scientific and/or medical journals preferred
Pharmacoepidemiology and Biostatistics knowledge preferred



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Staffing Now Company Type:
Company: Staffing Now
City:
State:
Zip:

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