Senior Medical Writing Consultant

5 giorni fa


Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno
Medical Writer Job Description

MMS Holdings Inc. is a leading Contract Research Organization (CRO) that provides innovative data-focused solutions to the pharmaceutical, biotech, and medical device industries. We are seeking a highly skilled Medical Writer to join our team.

Responsibilities:
  • Conduct thorough literature reviews to select primary resource materials for clinical development documents.
  • Write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, and integrated safety and efficacy summaries.
  • Meet tight deadlines and maintain a high level of quality in writing assignments.
  • Collaborate with clients to coordinate all facets of projects and provide excellent customer service.
  • Develop and maintain expertise in regulatory writing and clinical medical writing.
  • Lead and manage teams while authoring regulatory documents with aggressive timelines.
  • Stay up-to-date with federal regulations, Good Clinical Practices, and ICH guidelines.
Requirements:
  • At least 3 years of experience in the pharmaceutical industry.
  • 3-5 years of industry regulatory writing and clinical medical writing experience.
  • Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
  • Substantial clinical study protocol experience as lead author.
  • Excellent writing, organizational, and communication skills.
  • Proficiency in MS Word, Excel, PowerPoint, and related word processing tools.


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