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Drmarbys

Principal Medical Writer

Drmarbys, MI, United States

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MMS 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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years.

Responsibilities

  1. 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.
  2. 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, and presentation materials.
  3. Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
  4. Practice good internal and external customer service.
  5. Interact directly and independently with clients to coordinate all facets of projects.
  6. Mentor medical writers and other members of the project team involved in the writing process.

Requirements

  1. Bachelor’s, Masters, or PhD Degree in scientific, medical, clinical discipline, or related field is required with at least 6 years of previous regulatory writing experience; Masters or PhD degree is preferred.
  2. Substantial clinical study protocol experience as lead author required.
  3. Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  4. Exceptional writing and organizational skills are a must.
  5. Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
  6. Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Marketing, Public Relations, and Writing/Editing

Industries

Smart Meter Manufacturing

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