Scientific Technical Writer

Employer
Kelly Science, Engineering, Technology & Telecom
Location
Round Rock, TX
Closing date
Jul 1, 2022

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Sector
Science
Organization Type
Corporate
Location: Austin, Tx (local, remote)

Pay Rate: $35 hour

Contract Length: 9 months



How will you make an impact?



The Clinical Next-Generation Sequencing Team is seeking an experienced and highly motivated document specialist for the generation of design documents, test plans/reports, SOPs, and other documentation related to the development of sample collection, nucleic acid extraction workflows, and Next-Generation Sequencing development for regulated markets. The position involves applying experience in quality and regulatory documentation to support the R&D team in drafting documentation for new product development towards regulatory submissions. The candidate will have strong time-management and organizational skills, excellent proofreading and editing skills, strong understanding of regulated product development process (CE-IVD or US IVD) and QSR systems, and the ability to collaborate effectively with different functional groups including R&D, Regulatory, Quality, Product Management, Manufacturing, and external partners.

What will you do?
  • Prepare new product development documentation including study plans/reports, SOPs, and other technical documents
  • Proofread and ensure documents meets Quality and Regulatory requirements, guidelines, policies, and procedures
  • Facilitate and track the document routing and approval in collaboration with Core Team members and Document Management System change analysts
  • Actively participates with cross-functional new product development teams to ensure documents are in compliance with design controls per ISO 13485 and FDA QSR.
  • Generate templates and guidance documents in partnership with Regulatory and Clinical Affairs, Quality/Design Compliance, and other stakeholders
  • Standardize and streamline documents and documentation system in coordination with R&D team and managers
  • Aid in preparation of documents for regulatory submission
  • Proactively solicit information from other experts within the company as needed (e.g., R&D, Manufacturing, QA, QC, Legal)


How will you get here?



Education:
  • Master's Degree with 1-2 years writing experience.
  • Preferred BA/BS Degree, 5+ years/ MS Degree, 3+ years of industry experience


Experience:
  • At least 2 years prior experience writing and coordinating SOP and/or technical documents required.
  • Ability to work collaboratively in cross functional teams and provide pro-active communication is required.
  • Understanding of Quality Systems Regulations and Good Documentation Practice
  • Familiarity with phase-gate product development process
  • Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products
  • Experienced using electronic Document Management Systems
  • Highly skilled at using Microsoft Office (Word/Excel), able to create and manage styles, permissions, macros etc.
  • Experience in a lab setting in life sciences and/or an understanding of molecular biology and associated techniques


(Preferred):
  • Experience in Quality Assurance is a plus.
  • Preferred BA/BS Degree, 5+ years/ MS Degree, 3+ years of industry experience



Knowledge, Skills, Abilities:
  • Extremely organized and detail-oriented professional with excellent proofreading and editing skills
  • Ability to complete tasks in a fast-paced, cross functional environment with multiple concurrent projects
  • Driven to deliver quality results on time and in a highly ethical and professional manner
  • Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective
  • Must be tolerant to change, ready to take on new challenges and open to learning new skills
  • Science background with experience in Research and Development would be a plus. Need a person with a good understanding of the lab, experiments, product development.
  • Experience and knowledge in the Regulatory bodies is good.


***Remote position but must be local as may be required to be onsite from time to time. ***

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