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Senior Medical Writer

Senior Medical Writer

  • Location

    Crawley

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    £55k per year + Benefirs

  • Contact:

    Andrew Robb

  • Contact email:

    Andrew.Robb@catalystcareers.com

  • Contact phone:

    02035899243

  • Job ref:

    LM43165

  • Published:

    10 months ago

  • Expiry date:

    2020-02-11

Summary

My client, a niche CRO offering an excellent work environment and career development, are looking for their next Senior Medical Writer.

Job Responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Acts as lead for assigned writing projects.
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develops or supports a variety of documents that include, but not limited to:
    • Clinical study protocols and clinical protocol amendments;
    • Clinical study reports;
    • Patient narratives;
    • Clinical development plans;
    • IND submissions and annual reports;
    • Integrated summary reports;
    • NDA and (e)CTD submissions;
    • Investigator brochures, as well as;
    • Clinical journal manuscripts, clinical journal abstracts, and client presentations.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as peer reviewer on internal review team providing review comments on draft and final documents
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
  • Performs on-line clinical literature searches, as applicable.
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
  • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

Qualifications

  • Bachelor's degree in Science, Medical Technology, English, or equivalent experience.
  • Minimum 2 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
  • A PhD or MSc in Biology or health-related science is desirable and minimum three years + of experience in pharmaceutical medical writing is preferred
  • Familiarity with industry principles of drug safety, EU and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
  • Effective knowledge of company and sponsor-specific SOPs
  • Good written and oral communication skills.
  • Superior attention to detail.
  • Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
  • Fluent in word processing, flow diagrams and spreadsheets.
  • Good working knowledge of personal computer software programs in Windows environment.
  • Good communication, interpersonal, and team skills.
  • Ability to critically review own work before sending out for internal/external review by team.
  • Knowledge of regulations and standards affecting IVDs and Biologics