Senior Medical Writer
Veristat is expanding our presence internationally from our home office outside Boston to Montreal, Toronto, Research Triangle Park, Michigan, Taiwan, and most recently the United Kingdom.
We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly feedback conversations.
We invite you to learn more about us at our website www.veristat.com.
The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, clinical study reports, study protocols, investigator’s brochures, aggregate safety reports, and manuscripts.
As a Senior Medical Writer You Will...
- Conducts overall planning of the clinical sections of global submissions.
- Works with manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy.
- Advises management regarding project resource requirements, and manages project-related activities of resources assigned.
- Reviews statistical analysis plans and case report forms, as required.
- Performs quality control (QC) and “peer” review of clinical study reports and other submissions written by other medical writers.
- Keeps management informed on progress of documents and other project-related information.
- Assists management in projecting resources and performs administrative duties as requested.
- Works independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.
- Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by client and agreed per procedure.
Experience + Requirements
- Bachelor’s Degree in a science or related field.
- Minimum of 5 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
- Working knowledge of ICH and other regulatory guidelines required. The ability to accurately and clearly present clinical data, strong verbal, written, and interpersonal communication skills, and proficiency in MicroSoft Word required. Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred.
- Excellent regulatory writing skills (e.g., English usage) and a keen attention to detail also are required.