Senior Medical Writing Specialist
5 giorni fa
MMS Holdings Inc. is seeking a skilled Medical Writer to join our team. As a Medical Writer, you will be responsible for creating high-quality clinical development documents, including clinical protocols, investigator's brochures, and clinical study reports.
Key Responsibilities:- Evaluate and analyze medical literature to select primary resource materials for study design, statistical significance, and scientific rigor.
- Write and edit clinical development documents to ensure accuracy, clarity, and compliance with regulatory requirements.
- Collaborate with cross-functional teams to coordinate project timelines and workflow.
- Develop and maintain interpretive guides and take ownership of assignments.
- Mentor medical writers and other project team members involved in the writing process.
- At least 3 years of experience in the pharmaceutical industry.
- 3-5 years of industry regulatory writing and clinical medical writing experience.
- Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
- Substantial clinical study protocol experience as lead author.
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
- Exceptional writing skills, excellent organizational skills, and the ability to multi-task.
- Expertise in MS Word, Excel, PowerPoint, and related word processing tools.
- Experience as a project lead or managing a project team.
- A strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
MMS Holdings Inc. is a leading CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. We offer a dynamic and collaborative work environment, with opportunities for professional growth and development.
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