Job Description

JOB TITLE: SPEC 2, TECHNICAL WRITING

LOCATION:   CA - SAN JOSE, 95131

DURATION:  12 MONTHS

SHIFT TIME: IST SHIFT

SUMMARY:

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 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.

SKILLS:

• 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.

EDUCATION:

• Bachelor degree in relevant scientific discipline (Biological Sciences or Biomedical engineering focused on Biotechnology).
• Experience using flow cytometric analysis software (Diva, FlowJo, etc.)

PRIMARY DUTIES AND RESPONSIBILITIES

• Builds understanding of the literature and current medical opinion related to the BD products.
• Executes and leads literature review and 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.
• Has knowledge of BD Biosciences reagents and instruments.
• 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.

EXPERIENCE:

• A minimum of 2 years of relevant industry experience in product development or a combination of equivalent education and experience.
• Experience with BD flow cytometry systems (FACSCanto™, FACSLyric ™, BD LWA/SPA or LSR Fortessa™) and BD reagents preferred.
• Is self-motivated, detail and result oriented, willing to take risks and learn. Has previous experience with literature research and retrieval.

Company Description

MWIDM is a certified minority and women owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. With over a decade of experience, MWIDM provides Workforce Solutions to a broad range of business sectors including Systems Integration, Banking & Finance, Telecommunications, Life Sciences, Healthcare, Energy, Technology and Supply Chain. Established in 2004, MWIDM currently employs over 3,500 industry professionals supported by 38 national and international locations throughout the U.S., India and Canada. It’s an exciting time at MWIDM as we make significant investments in growing our Healthcare staffing division.