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Senior Medical Writing Consultant

1 mese fa

Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno
About MMS Holdings Inc.

MMS Holdings Inc. is a leading Contract Research Organization (CRO) that provides innovative, data-focused solutions to the pharmaceutical, biotech, and medical device industries. With a proven scientific approach to complex trial data and regulatory submission challenges, MMS supports clients in creating compelling submissions that meet rigorous regulatory standards.

Job Summary

We are seeking a highly skilled Medical Writer to join our team. The ideal candidate will have a strong background in regulatory writing and clinical medical writing, with experience in leading and managing teams while authoring regulatory documents with aggressive timelines.

Responsibilities
  • Critically evaluate, analyze, and interpret medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.
  • Write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications to medical journals.
  • Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
  • Practice good internal and external customer service and interact directly and independently with clients to coordinate all facets of projects.
  • Contribute substantially to the production of interpretive guides and mentor medical writers and other project team members involved in the writing process.
Requirements
  • At least 3 years of previous experience in the pharmaceutical industry.
  • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
  • The ideal candidate would hold a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
  • Substantial clinical study protocol experience, as lead author, is required.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines is essential.
  • Exceptional writing skills, excellent organizational skills, and the ability to multi-task are essential prerequisites.
  • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
  • Experience being a project lead or managing a project team is a plus.
  • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.