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20 days old

Scientific Technical Writer

Kelly Services
Austin, TX 78703
  • Jobs Rated
    43rd
**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. ***


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Jobs Rated Reports for Technical Writer

Posted: 2022-06-06 Expires: 2022-07-07

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Scientific Technical Writer

Kelly Services
Austin, TX 78703

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Technical Writer
43rd2019 - Technical Writer
Overall Rating: 43/199
Median Salary: $71,815

Work Environment
Very Good
32/220
Stress
Medium
93/220
Growth
Fair
91/220
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