Medical Writing Consultant for Regulatory Documents
2 settimane fa
MMS Holdings Inc. is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a data-driven approach to complex trial data and regulatory submission challenges.
Key Responsibilities:
- Critically evaluate, analyze, and interpret medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.
- 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.
- Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
- Practice good internal and external customer service and interact directly and independently with clients to coordinate all facets of projects.
- Contribute substantially to the production of interpretive guides and mentor medical writers and other project team members involved in the writing process.
Requirements:
- At least 3 years of previous experience in the pharmaceutical industry and 3-5 years of industry regulatory writing and clinical medical writing experience.
- A Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
- Substantial clinical study protocol experience as a lead author and experience leading and managing teams while authoring regulatory documents with aggressive timelines.
- Exceptional writing skills, excellent organizational skills, and the ability to multi-task.
- Expert proficiency in MS Word, Excel, PowerPoint, and related word processing tools.
- Experience as a project lead or managing a project team.
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