Clinical Development Writer
1 month ago
Clinical Development Writer
About the Job:MMS, a leading Contract Research Organization (CRO), is seeking an experienced Clinical Development Writer to join our team. As a Clinical Development Writer, you will play a crucial role in supporting the pharmaceutical, biotech, and medical device industries with high-quality clinical development documents.
Responsibilities:- Conduct thorough research and critically evaluate 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, Module 2.5 documents, presentation materials, and publications to medical journals.
- Prioritize writing assignments and maintain timelines to meet project deadlines.
- Demonstrate expertise in styles of writing for various regulatory documents and interact directly with clients to coordinate all facets of projects.
- Take ownership of assignments, proactively consulting other project team members and department representatives as necessary.
- Mentor junior writers and project team members involved in the writing process.
- At least 3 years of experience in the pharmaceutical industry.
- A minimum of 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.
- Proven experience leading and managing teams while authoring regulatory documents under aggressive timelines.
- Familiarity with regulatory submissions presented to regulatory authorities is an asset.
- Exceptional understanding of clinical data and outstanding writing skills are essential.
- Expertise in MS Word, Excel, PowerPoint, and related word processing tools.
- Previous experience as a project lead or managing a project team.
$80,000 - $110,000 per annum based on qualifications and experience.
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