Spec 2, Technical Writing

Technical Writer

Max Pay Rate: $43.30/hour
Max Bill Rate: $55/hour bill rate. Remote to start, but must be able to go to the office once a week when the site opens back up. Must be local to go onsite once a week. Part Time Schedule: Negotiable, a minimum of 3 days/week
Must haves on the resume: Understand China regulatory environment, excellent written communication skills, knowledge on flow cytometry
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 to 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 BD 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, with emphasis on Great Asia.
Primary duties:
Builds understanding of the literature and medical opinion related to the BD products.
Executes and leads literature review, appraisal activities and documentation according to BD procedures.
Possesses strong analytical skills and excellent written communication skills to develop, review/ edit, obtain feedback and approval of BD documentation for BD technical files.
Is accountable for completion of the activities related to milestones.
Presents summaries and updates during group meetings.
Has knowledge of BD 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 previous experience in international registrations of IVD products, with focus on the China regulatory environment.
Has excellent verbal communication skills and ability to work effectively in a matrixial work environment.
Is self-motivated, detail and result oriented, willing to take risks and learn. Has previous experience with literature search 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:
Is familiar or has used the BD flow cytometry systems (FACSCanto™, FACSLyric ™, BD LWA/SPA or LSR Fortessa™) and BD reagents preferred.
Experience using flow cytometric analysis software (Diva, FlowJo, etc.)
Primary Work Location: USA CA - San Jose.