Demo

Abacus Staffing is hiring: Technical Writer - I in Orlando

Abacus Staffing
Orlando, FL Full Time
POSTED ON 2/7/2025
AVAILABLE BEFORE 5/6/2025

RESPONSIBILITIES :

  • Directly participate in new product development projects, with the primary responsibility being the creation of high-quality written content to support Scientific Affairs tasks.
  • Conduct meetings, communicate, and implement an operational plan for completing Scientific Affairs tasks / milestones.
  • Monitor progress and performance against the project plan.
  • Set priorities, allocate tasks, and coordinate with the Scientific Affairs team to meet project targets and milestones.
  • Daily interaction with technical documentation, with documentation tasks to be performed with quantitated high-throughput and attention to detail.
  • Required to proofread, prepare, create, review, edit, and update Quality and Technical Documents including, but not limited to : SOPs, Design Control Documentation (Customer Requirements and Product Requirements), State-of-the-Art, Clinical Performance, Scientific Validity Protocols and Reports. Also assists the product labeling team draft Explanation of Test.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.
  • Responsible for exhibiting professional behavior with both internal / external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal / external working relationships.
  • Learn complex concepts and communicate the information in a way that is engaging and understood by users.
  • Manage and update revisions to technical literature.
  • Maintain a comprehensive library of technical terminology and documentation.
  • Carries out duties in compliance with established business policies.

Adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.

Perform other duties & projects as assigned.

MINIMUM QUALIFICATIONS | EDUCATION / EXPERIENCE :

  • Bachelor's degree from an accredited university.
  • Proven experience in a technical writing position.
  • Minimum of 2 years of technical writing experience in a GMP / Biotech / Pharma / Regulated Industry.
  • PREFERRED QUALIFICATIONS :

  • Demonstrated success in Technical Writing in the GMP / Biotech / Pharma / Medical Device / Regulated Industry.
  • Very strong written and verbal communication skills.
  • Strong experience owning the end-to-end documentation creating process.
  • Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.
  • Experience in Quality Assurance / Regulatory requirements in the medical device / pharma / biotech industry.
  • COMPETENCIES :

  • Very strong attention to detail.
  • Must be coachable and must follow written and verbal direction.
  • Must be able to productively generate quality documentation to meet program timelines.
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