Our client, a leading medical devices company is looking for a Medical/Scientific Technical Writer. This is for an initial duration of 12 months and is located in San Jose, CA
· Technical Writer is an integral member of Medical and Scientific Affairs function responsible for supporting development, review and obtain approval of the documents with medical sciences content.
· Activities will include writing, editing, and maintaining high quality content of the medical affairs documentation supporting regulatory submissions.
· Also, s/he will contribute on the collection and appraisal of the published literature; review document labeling for compliance for In Vitro regulatory status or RUO labeling status.
· S/he has knowledge of reagents, flow cytometry technology, automated sample preparation instruments, as well as product development practices in commercial settings. S/he understands regulatory requirements for IVD and promotional activities.
· Builds understanding of the literature and current medical opinion related to the products.
· Executes and leads literature review and appraisal activities and documentation according to procedures.
· Possesses strong analytical skills and excellent written communication skills to develop, review/ edit, obtain feedback and approval of documentation for technical files.
· Is accountable for completion of the activities related to milestones.
· Presents summaries and updates during group meetings.
· Has knowledge of reagents and instruments.
· Is willing to learn and participate in cross-functional teams to advance technical and regulatory knowledge and skills.
· Works under general supervision and reports to the Senior Manager.
· Bachelor degree in relevant scientific discipline (Biological Sciences or Biomedical engineering focused on Biotechnology).
· A minimum of 2 years of relevant industry experience in product development or a combination of equivalent education and experience.
· Has excellent verbal communication skills and ability to work effectively in across interdisciplinary team-based work environment.
· Is self-motivated, detail and result oriented, willing to take risks and learn. Has previous experience with literature research and retrieval.
· Has working knowledge of MS Office, Adobe Acrobat, strong MS Excel skills.
· Is extremely motivated, willing to work in a fast-paced within a matrixial organization and team-based work environment.
· Experience with flow cytometry systems (FACSCanto™, FACSLyric ™, LWA/SPA or LSR Fortessa™) and reagents preferred.
· Experience using flow cytometric analysis software (Diva, FlowJo, etc.)
Qualified candidates please send your word format updated resume at the earliest to email@example.com. Thank You.
Sunrise Systems Inc
Why Work Here?Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.
Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.