24 days old

Senior Medical Writer

Greenwich Biosciences, Inc.
Richmond, VA 23219
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  • Job Code
    R0001514-1
We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.

Job Purpose

To undertake various medical writing and quality control activities.

Responsibilities

  • Complete medical writing activities to appropriate quality standards and required timelines.
  • Mentor new staff members and deliver training, as required.
  • Identify additional training needs of the medical writing team and liaise with line manager to implement training.
  • Undertake quality control checks on company documentation as requested, to required timeline.
  • Maintains GCP and Health & Safety knowledge as applicable to the job.
  • Standard operation procedure (SOP) and Guideline writing, implementation and maintenance.

Writing, formatting, review, or QC checking of the following essential documents:

  • Clinical study protocols.
  • Clinical study reports.
  • Informed consent forms/information leaflets.
  • Documents contained in the modules of the Common Technical Document (CTD).
  • Investigator Brochures.
  • Briefing documents.
  • Greenwich guidelines and templates.
  • Conducts literature reviews and summarizes relevant information.
  • Writes, prepares, and/or QC checks other clinical documentation, as applicable.
  • Writes Greewich Biosciences SOPs and Guidelines, and updates related documents, as required.
  • Ensures relevant clinical trial information is uploaded onto ClinicalTrials.gov in accordance with regulatory requirements and uploads the final results to trial records.
  • Mentors new staff members, shadowing work, and delivering training, as required.
  • Is responsible for ensuring up-to-date with company SOPs, relevant regulations and legislation and to ensure that company documentation meets with these standards.
  • Carries out their work in a way that will not adversely affect their own, or others, health, safety and security or the environment and reports any shortcomings in Greenwich Biosciences arrangements.

Required Experience

  • Scientific graduate; PhD in Biomedical Sciences desired.
  • 5 + years of industry experience or relevant research, ideally in safety, regulatory or clinical areas, preferably including at least 3 years of medical writing experience.
  • Good knowledge of relevant regulations and legislation.
  • Excellent written skills with ability to interpret data and express findings in a clear and concise manner.
  • Excellent attention to detail.
  • Excellent organizational and time management skills.
  • Excellent communication skills including ability to work with colleagues across all clinical development functions.
  • Comprehensive computational skills, particularly in the use of Microsoft packages.
  • Ability to be proactive, to work on own initiative and as part of a team.
  • Flexibility in meeting challenging deadlines and changing requirements.
  • Develops and maintains positive working relationships with others.
  • Shares ideas and information.
  • Assists colleagues as and when required.
  • Demonstrates a can do approach.

Preferred

  • Medical background enabling, for example, enhanced interpretation and understanding of laboratory results, clinical findings, drug interactions etc.

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Posted: 2020-03-14 Expires: 2020-04-12

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Senior Medical Writer

Greenwich Biosciences, Inc.
Richmond, VA 23219

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