[Hiring] Principal Medical Writer @MMS

Role Description

This role involves working as a Medical Writer with responsibilities including:

• Critically evaluating, analyzing, and interpreting medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.
• Writing and editing clinical development documents, including but not limited to:
  • Clinical protocols
  • Investigator’s brochures
  • Clinical study reports
  • Subject consent forms
  • Integrated safety and efficacy summaries
  • Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents
  • Presentation materials and publications to medical journals
• Completing writing assignments in a timely manner.
• Maintaining timelines and workflow of writing assignments.
• Practicing good internal and external customer service.
• Being highly proficient with styles of writing for various regulatory documents.
• Having expert proficiency with client templates & style guides.
• Interacting directly and independently with clients to coordinate all facets of projects; demonstrating competent communication skills for projects.
• Contributing substantially to, or managing, the production of interpretive guides.
• Taking ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as necessary.
• Mentoring medical writers and other members of the project team involved in the writing process.

Qualifications

• 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.
• 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 is a plus.
• Understanding of clinical data.
• Exceptional writing skills are a must.
• Excellent organizational skills and the ability to multi-task are essential prerequisites.
• 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 is a plus.
• Not required, but experience with orphan drug designations and PSP/PIPs is a plus.

Requirements

• Experienced.