Scientific Communications Medical Writer

2 weeks ago

West Lafayette, United States Cook Group Full time

Overview:
Cook Research Incorporated (CRI) is a dynamic company that is focused on improving patient care and is staffed with a diverse group of professionals, scientists, and technicians who have expertise in medical products. The highly talented and creative CRI team performs hundreds of in vivo and in vitro tests, manages regulatory submissions globally, and supports clinical studies from pre-market to post-market phases of product development.

**Responsibilities**:

- Write and direct the preparation of clear and comprehensive Clinical Evaluation Plans and Clinical Evaluation Reports;
- Conduct systematic, comprehensive searches for published medical literature;
- Provide interpretation and analysis of clinical/scientific data;
- Lead the planning, development, and delivery of high-quality documents with a proactive approach to project management, including development of project timelines and communication of the process and timelines to stakeholders;
- Arrange and conduct stakeholder meetings with cross-functional teams;
- Resolve document content issues and questions that arise from the writing/review process;
- Provide status updates on deliverables to management;
- Understand medical writing and regulatory standards and practices;
- Proactively contribute to process improvements and knowledge sharing initiatives;
- Ensure consistency across and within documents; and
- Other duties as assigned.

Qualifications:

- PhD in a life science or biomedical engineering discipline or PharmD preferred (or equivalent regulatory/writing experience);
- Familiarity with focused literature searches through several search databases;
- Familiarity with statistical methods, data analysis, and interpretation;
- Ability to understand and interpret clinical/scientific data and to present results in an understandable and concise manner;
- Ability to work on multiple projects, organize, and prioritize within time constraints;
- Ability to work both independently and collaboratively in a cross-functional team environment;
- Competence with Microsoft Office software;
- Competence with a reference management software;
- Excellent written, verbal, and interpersonal communication skills with attention to detail (to detect inconsistencies or errors in various types of documents and communications); and

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