Senior Medical Writing Consultant

3 settimane fa


Roma, Lazio, Italia Mms Holdings Inc A tempo pieno
Medical Writer - Regulatory Affairs

MMS Holdings Inc is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.

As a Medical Writer - Regulatory Affairs, you will be responsible for critically evaluating, analyzing, and interpreting medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.

You will 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.

Key Responsibilities:

  • Critically evaluate, analyze, and interpret medical literature to select primary resource materials
  • Write and edit clinical development documents
  • Maintain timelines and workflow of writing assignments
  • Practice good internal and external customer service
  • Interact directly and independently with clients to coordinate all facets of projects

Requirements:

  • At least 3 years of previous experience in the pharmaceutical industry
  • At least 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

MMS Holdings Inc is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.

We are looking for a highly skilled Medical Writer - Regulatory Affairs to join our team.



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