Scientific Technical Writer
- Employer
- Kelly Science, Engineering, Technology & Telecom
- Location
- Round Rock, TX
- Closing date
- Jun 29, 2022
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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?
How will you get here?
Education:
Experience:
(Preferred):
Knowledge, Skills, Abilities:
***Remote position but must be local as may be required to be onsite from time to time. ***
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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