Job Description

Job 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 Micro Vention® 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. Some typical job duties include:

• 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

1. BA/BS degree
2. Three (3) to five (5) years of scientific experience.
3. Demonstrated experience in the development of regulatory/ clinical submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients).
4. Excellent writing and editing skills, and attention to detail.

Desired Qualifications

1. Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH). Experience as author or contributor of peer-reviewed manuscripts is strongly desired.
2. Strong verbal, written, and interpersonal communication skills.
3. Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote.
4. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.

Additional Information

• The primary work location for this position is Tustin, CA (the company will be relocating to a new facility in Aliso Viejo, CA in Q3 2017).
• Relocation may be available for qualified candidates.
• Candidates must be eligible to work in the U.S. and not require visa sponsorship.
• For more information, visit our web site at

Job Tags

Interim role, Relocation,

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