Senior Medical Writer

4 settimane fa


Roma, Lazio, Italia Trilogy Writing and Consulting A tempo pieno

Job Title: Senior/Principal Medical Writer

Company: Trilogy Writing & Consulting

We are seeking a highly skilled Senior/Principal Medical Writer to join our team at Trilogy Writing & Consulting. As a Senior/Principal Medical Writer, you will be responsible for preparing clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures. You will work closely with clients and authors to ensure that all documents are produced according to agreed timelines and meet the requirements of Trilogy and our clients.

Key Responsibilities:

  • Prepare clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures
  • Work closely with clients and authors to ensure that all documents are produced according to agreed timelines
  • Ensure that all documents meet the requirements of Trilogy and our clients
  • Provide document-specific advice to clients
  • Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility

Requirements:

  • Relevant professional experience actively writing regulatory documents
  • Worked as the lead writer on at least 3 (Senior Medical Writer) or 5 (Principal Medical Writer) of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications
  • For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers
  • Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines
  • Competency in the use of document management systems and review tools

What We Offer:

  • Remuneration relative to the level of experience
  • Standard Trilogy benefits

How to Apply:

  • Submission of documents in English, including CV and cover letter specifying how you comply with the experience requirements

Equal Employment Opportunity:

Trilogy Writing & Consulting complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state/provincial, and local law.



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