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Regulatory Writer

2 months ago

London, Greater London, United Kingdom MMS Full time

MMS 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.

Key Responsibilities
  • Critical Evaluation and Analysis: 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.
  • Document Writing and Editing: Write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.5 documents, presentation materials, and publications to medical journals.
  • Timely Completion and Project Management: Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
  • Regulatory Document Writing: Highly proficient with styles of writing for various regulatory documents.
  • Client Communication and Project Coordination: Interact directly and independently with clients to coordinate all facets of projects; competent communicator skills for projects.
  • Team Leadership and Mentorship: 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
  • Education and Experience: Bachelor's, Master's, or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Master's or PhD degree is preferred.
  • Leadership and Management Experience: Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  • Regulatory Submissions Experience: Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus.
  • Clinical Data Understanding: Understanding of clinical data.
  • Writing and Technical Skills: Exceptional writing skills are a must. Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
  • Project Lead or Management Experience: Experience being a project lead, or managing a project team.