14 days old
2017-11-062017-12-04

Technical Writer

Morrisville, NC 27560
  • Job Code
    586204

We have a 6 month renewable position for a Technical Writer with a client of ours in RTP, NC. Candidate must have experience in an FDA regulated environment. Technical Writers will work closely with the relevant development and Systems Validation Testing (SVT) teams to document various artifacts included in the Software Development Life Cycle (SDLC). Technical Writers will be responsible for liaising with the development team and Subject Matter Experts (SMEs) to understand the scope of each application as well as pulling the existing information from the various SOPs to better understand product scope, product requirements and product risks as they relate to patient safety, data integrity and overall product quality.


RESPONSIBILITIES


- Draft various SDLC artifacts including but not limited to:


o Master Validation Plans


o Test Protocols


o Risk Assessments


o 21 CFR Part 11 checklists


o Validation Reports


- Strong knowledge of Microsoft Office and other data capture and compilation tools


- Exemplary technical/procedural writing skills; ability to think through step-by-step procedures


- Proficient written and verbal communication skills


- Strong attention to detail/quality control; consistent follow-through


- Competent presentation and interpersonal skills


- Proficient planning skills


- Ability to establish and maintain effective working relationships with team members and SMEs, including in a virtual setting


MINIMUM REQUIRED EDUCATION AND EXPERIENCE


Professional technical writer with several years' experience in authoring SDLC artifacts for commercial or custom applications, ideally in the medical/clinical domain


PHYSICAL REQUIREMENTS


- Extensive use of telephone and face-to-face communication requiring accurate perception of speech


- Extensive use of keyboard requiring repetitive motion of fingers


- Regular sitting for extended periods of time

Categories

  • Information Technology

Randstad utilizes a technology-driven focus with a human touch to provide better staffing and business solutions to organizations around the world. Our team of experts match professionals with available career opportunities in a variety of fields.

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Technical Writer

Randstad Technologies
Morrisville, NC 27560

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Technical Writer

Randstad Technologies
Morrisville, NC
US

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