Sr. Medical Writer Peripheral Vascular Med Device (U.S. Remote)

MicroVention
•$145,000 - $155,000•Remote

About The Position

The Sr. Medical Writer/Medical Writer will act as the primary contact for medical writing projects, working cross-functionally with Terumo Neuro departments and clients to set and meet internal and external deliverables. This role involves collaborating with clinical and regulatory teams to write clinical documents for regulatory submissions, researching and editing clinical reports and scientific presentations, conducting literature searches, and assisting in the creation of clinical educational materials.

Requirements

  • 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.
  • 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.

Nice To Haves

  • 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.

Responsibilities

  • Act as primary contact for medical writing projects, cross-functionally working with Terumo Neuro departments and clients to set and meet internal and external deliverables.
  • Collaborate 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.
  • Conduct literature searches, manage the literature database and prepare literature reviews for external and internal clients.
  • Assist in the creation of clinical educational materials for the global Sales & Marketing organizations.
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