Xencor seeks a Technical Writer for its Monrovia office. Duties include Preclinical Technical Writing and Project Management: Manage contributing scientist teams in the generation of Research Technical Reports needed to support regulatory filings; Draft, edit or proofread Technical Reports and Regulatory Documents; and Review and edit technical documents from CROs and consultants; Quality Control Technical Writing: Draft, edit, or proofread Analytical Methods (AM), AM Qualification and Validation Plans and Reports, and Standard Operation Procedures, in collaboration with contributing scientists; and Technical Investigations Writer (deviations, change controls, CAPAs); Document Control Manager: Establish and maintain document templates; SOP lifecycle management; Report lifecycle management; Centralized document control manager in Veeva Vault systems; Initiates and supports continuous improvement initiatives; Maintain current knowledge of the field and area(s) of technical expertise and development; Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task; assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors; and Performs other related duties and responsibilities, on occasion, as assigned. Position requires a bachelor’s degree in communications, marketing, biology or related discipline and one year of progressively responsible experience as a technical writer in a medical or biotechnology environment.
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