Senior Medical Writing Consultant

2 settimane fa

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

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.

We are seeking a highly skilled and experienced Regulatory Document Specialist to join our team.

Responsibilities:

  • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor, and absence of bias.
  • Write and edit clinical development documents, including but not limited to, 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.
  • Maintain timelines and workflow of writing assignments.
  • Practice good internal and external customer service.
  • Highly proficient with styles of writing for various regulatory documents.
  • Expert proficiency with client templates & style guides.
  • Interact directly and independently with clients to coordinate all facets of projects; competent communicator skills for projects.
  • Contribute substantially to, or manages, production of interpretive guides.
  • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary.
  • Mentor medical writers and other members of the project team who are 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, required.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus.
  • Understanding of clinical data.
  • Exceptional writing skills are a must.
  • 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.
  • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus.
  • Substantial clinical study protocol experience, as lead author, required.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  • Not required, but experience with orphan drug designations and PSP/PIPs a plus.

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