Posted 1w ago

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

@ MicroVention
Aliso Viejo, California, United States
$145k-$155k/yrRemoteContract
Responsibilities:write documents, conduct literature, edit reports
Requirements Summary:Senior medical writer with 3-5 years of scientific experience; experience developing regulatory/clinical submissions for medical devices; excellent writing/editing skills.
Technical Tools Mentioned:Microsoft Office, EndNote, PubMed, MedLine
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Job Description

Job Description

This is a Temp-To-Hire Position

The Sr. Medical Writer/Medical Writer
will 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.  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.

Location MV

Aliso Viejo, California, USA

Department Name

800-California Interventional Systems (CAIS)

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.
EEO
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance
If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. 

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title

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

Posting Country

US - United States

Salary Range

$145,000 - $155,000 Financial compensation packages may be higher/lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)