Max Pay Rate: $55/hour pay rate.
Primary Work Location: USA CA - San Jose.
Description:
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.
Primary duties:
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 Biosciences 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.
Minimum Qualifications:
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.
Preferred Qualifications:
Experience with flow cytometry systems (FACSCanto, FACSLyric , LWA/SPA or LSR Fortessa) and reagents preferred.
Experience using flow cytometric analysis software (Diva, FlowJo, etc.
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Last updated on Oct 23, 2020