Covance

  • Medical Writer II - Early Phase

    Job Location(s) US-NJ-Princeton | US-NC-Raleigh-Durham | US-MA-Boston | US-TX-Austin
    Job Number
    2018-25680
    Job Category
    Medical Writing
    Position Type
    Full-Time
  • Job Overview

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

    Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

     

    Covance has a job opening for a Medical Writer II.  Person can be home or office based in the US or Canada. 

     

    The Medical Writer II is the Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Production of scientific publications and other documents (e.g. abstracts, posters, manuscripts, etc). Oversees and coordinates other writers on CSR appendices compilation and narrative projects. Prepare and review patient safety narratives and CSR appendices. Ensure timely delivery of high quality documents to internal

    customers and Sponsors. Works with the management team to provide training to Medical Writers to ensure best working practices are maintained. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

     

    •  Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate
    • Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs
    • Prepare and review patient safety narratives
    • Leads project management and coordination of narrative projects
    • Oversee and coordinate other writers on CSR appendices compilation
    • Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
    • Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
    • Incorporates internal and/or external review comments on clinical documentation
    • Prioritize and forward plan workload to a high standard; to advise Management of problems promptly
    • Participate independently in internal and external client meetings. Lead meetings as appropriate
    • Responsible for project coordination and adherence to project timelines and budget
    • Identify ways to improve the efficiency and quality of work processes
    • Mentor Associate Medical Writers and Medical Writer I, as appropriate
    • Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience
    • Provide training to Medical Writers and other staff as appropriate
    • Represent department in audits and inter-department working groups
    • Comply with Covance internal processes and procedures
    • Performs other duties as assigned by Management

    Education/Qualifications

    Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred

    Experience

    * Typically minimum 3 years medical writing experience including 1 year as medical writing project lead

    * Excellent command of written and spoken English

    * Good written and verbal communication skills

    * In-depth knowledge of MS Word

    * Good organizational and time management ability

    * Excellent interpersonal skills

    * Knowledge of ICH guidelines applicable to medical writing

    * Good understanding of medical/scientific terminology and experience in data analysis and interpretation

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