Sub Banner Default Image
Home / Jobs /

Principle Medical Writer

Principle Medical Writer

Back to job search

Principle Medical Writer

  • Location:

    England

  • Sector:

    Medical Communications - Pharma

  • Contact:

    Arslan Sabir

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04232_1667912331

  • Published:

    30 days ago

  • Duration:

    12 Months

  • Startdate:

    ASAP

MSI Pharma have partnered with a leading pharmaceutical company seeking a Principle Medical Writer.

Experience

  • More than 3 years of study related and submission related clinical regulatory documents
  • Experience of writing protocols, CSRs, IBs, Briefing Documents
  • Experience of writing relevant documents for more than 3 drug products in Oncology and Immuno-oncology
  • Leading the delivery for individual documents, setting clear expectations for completion of assignments to expected timelines and quality.

Qualifications

  • MSc or PhD in Life Science
  • Understand the role of other functions in document development (e.g. statistics, clinical, regulatory, safety, etc.)
  • Serve as a knowledgeable resource on regulatory requirements (eg, GCP, ICH, CTD) and relevant internal/external guidelines.
  • Understand complex clinical study design and statistical concepts, terminology, and analyses within text and tables/figures.