Jr. Medical Writer

Troy - Michigan - United States - Life Sciences & Health Care - Pharmaceutical - Clinical - Academic Bachelor

The Medical Writer assists in the planning and execution of general medical writing activities including systematic literature reviews, Clinical Evaluation Reports (CER), Post-Market Clinical Reports (PMCRs), and other clinical research documents as needed (e.g. clinical study reports) for assigned therapeutic area and projects.

Feel free to contact

Haley Davies, Account manager

Apply now

About this role

  • Prepares clinical research documents containing clinical and technical data in support of JJV’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.

About you

  • BA, BS, or BSN is required; advanced degree is preferred;
  • Three (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;
  • Strong oral communication, presentation, project management and prioritization skills;
  • Excellent interpersonal relationships;
  • Highly proficient in Microsoft Office Suite (MS WORD in particular) and bibliographic software (e.g. Endnote, Reference Manager).

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB213197
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Clinical
  • Closing date: Friday, July 5, 2019
Apply now

Feel free to contact

HD

Haley Davies

Account manager Brunel Canada Toronto

+1 416 244 2402

Related vacancies

    Job Alert

    Send me an email with the latest vacancies matching Jr. Medical Writer - Michigan

    Search query is invalid or corrupted You are already subscribed to this Job Alert (duplicate)
    Frequency is not correctly filled in
    Please enter a valid email address
    When creating a Job Alert you agree to our Privacy Statement. You can adjust or cancel your Job Alert at any time.

    Confirmation sent to