Employer Industry: Medical Device Company
Why Consider this Job Opportunity:
- Salary up to $172,500.00
- Opportunity for career advancement and growth within the organization
- Remote work opportunity with quarterly travel to headquarters
- Chance to contribute to advances in the medical community
- Collaborative work environment
- Access to comprehensive benefits package including medical, dental, and vision insurance, life insurance, flexible spending account, matching 401(k), annual bonus, and more
What to Expect (Job Responsibilities):
- Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support clinical study design
- Combine an understanding of scientific and research methodology and medical device regulations and guidelines to support clinical research technical writing needs
- Extract statistical data summaries, study conduct information, and study design information to prepare interim and final study reports
- Prepare clinical study documents and coordinate with additional collaborators including product management, statistician, regulatory affairs, clinical research management, and contract research organizations (CROs)
- Manage timelines required by product development and clinical research teams for technical writing deliverables and communicate progress to cross-functional teams
- Ensure documents are produced per procedures, internal and external guidelines, and electronic templates
What is Required (Qualifications):
- Master's degree required, PhD preferred
- 4 years of relevant clinical research experience required
- 2 years of experience in technical/scientific writing in the medical device industry is required
- Strong knowledge of orthopedic medical and surgical terminology is required
- Previous experience writing study protocols, manuscripts for publication, interim study reports, and final study reports is required
- Relevant certification required, or willing to obtain in one year
How to Stand Out (Preferred Qualifications):
- 0-2 years of experience as a Clinical Research Technical Writer in the medical device industry
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