glassdoor.com sales-marketing technical writer- serialization - remote based

Technical Writer- Serialization - Remote Based


USDM Life Sciences Overview

USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and manufacturing operations while staying in compliance with FDA regulations. USDM disrupts convention and delivers compliance with proficiency, simplicity, and efficiency to achieve better results for our customers that are in the business of saving lives. It’s a place where you can make an impact in the world as a champion for life sciences innovation and also get the experience and mentoring to grow your career.

Founded in Santa Barbara, California in 1999 by two UCSB graduates, USDM has grown to a global company with offices throughout the US, Toronto, Canada and Frankfurt, Germany.

Job Description

USDM needs a strong Technical Writer with SAP ATTP or strong serialization experience. Will focus on developing SOPs, forms and Work Instructions to support business process operation
  • USDM is looking for an enthusiastic Technical Writer to join our team. Responsibilities will include:Conduct interviews with content provider(s)/author(s)
  • Draft documentation based on limited content or drafts provided by author(s) and from technical documentation
  • Provide updates to drafts based on content providers input
  • Adherence to corporate communication standards
  • Ensures that all documents are technically and mechanically accurate, consistent with internal style guidelines, and consistent with regard to clarity, flow, organization, completeness, accuracy, readability, and/or appropriateness.
  • Interacts with appropriate departments to establish priorities and deadlines for technical documentation.
  • Facilitates the review and approval process and liaises with the business process owner to ensure the document intent is achieved.
  • Verifies own work and ensures the correct and timely implementation of all documentation.
  • Checks format and compliance to company templates.
  • Participates in cross-functional project teams.
  • Performs other related duties and assignments as required.
  • Demonstrates analytical problem solving skills.
Qualifications
  • Excellent grammar and spelling skills
  • At least 3 years past experience writing and revising controlled documentation (e.g. procedures, work instructions, forms, specifications, protocols, reports, etc.) in the Life Science industry
  • Well versed collaborating with cross functional teams and SME’s
  • Experienced as both a writer and editor in creating system documentation, SOPs, specifications, training materials and deviation writing
  • Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
  • Ability to work independently.
  • Strong organizational/ facilitation/communication skills.
  • Strong verbal, written and presentation skills.
Education & Certifications
  • University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
  • Minimum 3 to 5 years in pharmaceutical industry, focusing on Systems Validation.
  • Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

USDM Life Sciences is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran, disabled, or any other protected status.
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