Jr. Medical Writer

Highly Competitive
  1. Permanent
  2. Medical Writing
  3. United States
Santa Ana, California
Posting date: 09 May 2019

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Jr. Medical Writer position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its California-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

Job Responsibilities:

  • Prepares clinical research documents containing clinical and technical data in support of the company's medical device product lines.
  • Participates in the planning and execution of clinical documents for assigned therapeutic area and projects including systematic literature reviews, post-market clinical reports (PMCRs), clinical evaluation reports (CERs)/plans (CEPs), clinical study reports (CSRs), and other clinical documents as needed (e.g. new clinical documents related to the upcoming 2020 EU MDR regulations).
  • Communicates with other writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, product safety, etc. to correctly incorporate clinical and technical content.
  • Completes document formatting and layout.
  • Assist literature searches (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation.
  • Utilize software to support the core process steps for systematic literature reviews (e.g. Distiller).
  • 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.
  • Understands, interprets and summarizes complex results from the scientific literature including statistical results of clinical studies; presents results in a clear, concise and scientifically accurate manner for various end users (e.g. regulatory bodies, etc.)
  • Collects and compiles available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF updates, etc.), completion of post-market clinical reports (PMCRs) for product surveillance.
  • Ensures maintenance of CERs/CEPs and CER/CEP updates in a document control management system (e.g. Agile).
  • Prepares/assists clinical study report generation by tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents.
  • Incorporates text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner with proper formatting.
  • Works in a team with other clinical research personnel and external medical writers for generation of clinical documents.
  • Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7/1) and electronic templates.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Maintains compliance with state, federal and international regulations.

Skills and Requirements:

  • BA, BS, or BSN is required; advanced degree is preferred.
  • 3 years of related job experience in medical or scientific writing; less than 3 years with advanced degree (M.S. or higher) may be acceptable.
  • Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation preferred.
  • Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane) preferred.
  • Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting 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) preferred.
  • Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at +267 983 0134 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.