C. R. Bard, Inc.

  • Clinical Sciences Technical Writing Specialist

    Posted Date 4 weeks ago(4 weeks ago)
    Job ID
    Career Level
    US-NJ-Murray Hill
  • Overview

    The Clinical Sciences Technical Writing Specialist works closely with Medical Affairs, Principal Investigators and statisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc.

    Summary of Position with General Responsibilities

    The Clinical Sciences Technical Writing Specialist serves a medical research function and applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development and implementation of clinical studies. The primary objective and purpose of this position is ensuring that clinical trial protocols and study reports are developed and written with scientific rigor. He / she is responsible for all aspects of clinical science technical writing including researching, developing and writing study protocols, investigator brochures, study summaries, clinical study reports, or other clinical documents. The Technical Writing Specialist may participate in the scientific aspects of clinical studies throughout the duration of the study including  providing guidance to address questions regarding scientific and related procedural issues from investigators. He / she will support clinical teams as the medical writing representative, bearing the responsibility for timely and accurate completion of medical writing deliverables.

    Essential Job Functions

    • Conduct background research on indications and studies to establish references and scientific base;
    • Utilize knowledge of clinical trial design to develop clinical study protocols;
    • Participate in discussions concerning scientific and procedural aspects of study design;
    • Develop clinical study documents (study protocol, investigator brochures, consent forms, study reports, etc.) in accordance with FDA and International regulations;
    • Provide input to the design of CRFs;
    • Assist in identifying and resolving issues related to study design and execution;
    • Assist with the ongoing review of summary data including safety, primary efficacy variables and lab data;
    • Assist in the preparation and review of key regulatory documents, submissions, and annual reports.
    • Plan, draft and revise scientific manuscripts/abstracts for publication/presentation;
    • Support business units with posting of protocols, study results and adverse events report on ClinicalTrials.gov.

    Basic Qualifications

    • Minimum of BS or equivalent, MPH, MS, PharmD or PhD in field relevant to clinical research preferred
    • Minimum 3 years of experience with PharmD or Ph.D, 5 years with MS and 8 years with BS
    • Must be able to use scientific and clinical knowledge to conceptualize study designs
    • Must demonstrate excellent writing and organizational management abilities
    • Familiar with clinical operations and FDA and HIPAA rules, regulations and guidelines 
    • Knowledge of good document management practices

    Additional Desirable Qualifications Skills and Knowledge

    • Ability to anticipate and resolve problems
    • Ability to lead cross functional efforts and teams
    • Proficiency in data interpretation
    • Clinical project management skills
    • Excellent skills in oral and written communications
    • Ability to work independently with minimal guidance as well as collaboratively within a team setting

    Education and/or Experience

    • Minimum of BS or equivalent, MPH, MS, PharmD or PhD in field relevant to clinical research preferred
    • Minimum 3 years of experience with PharmD or Ph.D, 5 years with MS and 8 years with BS

    Physical Demands

    This position requires the ability to perform activities consistent with general office/ administrative work.

    Work Environment

    This position is based in a general office/administrative environment.  It also involves travel to off-site locations including clinician’s offices, health care settings, and occasional visits to intensive care units and/or operating suites.

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