Description
INNOVATION STARTS WITH YOU Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer. Position Overview The Sr. Medical Writer/Medical Writer will act as primary contact for medical writing projects, cross-functionally working with MicroVention departments and clients to set and meet internal and external deliverables
Responsibilities
- Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to
- Clinical evaluation reports
- Interim and final clinical study reports
- Briefing documents
- Previous human experience summaries
- Investigator brochures
- Study protocols
- Medical literature analysis reports
- Research, create, and edit assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, KOLs and physician investigators.
- Conducting literature searches, manage the literature database and prepare literature reviews for external and internal clients.
- Assisting in the creation of clinical educational materials for the global Sales & Marketing organizations.
Qualifications
- BA/BS degree.
- Three (3) to five (5) years of scientific experience.
- Demonstrated experience in the development of regulatory/ clinical submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients).
- Excellent writing and editing skills, and attention to detail.
Desired Qualifications
- Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH). Experience as author or contributor of peer-reviewed manuscripts is strongly desired.
- Strong verbal, written, and interpersonal communication skills.
- Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote.
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.
