Technical Writer

Purpose of Position/Essential Duties:

  • Explain technical ideas in simple language
  • Own end-to-end documentation creation process
  • Work closely with internal teams to deeply understand product and documentation requirements
  • Write, edit, and review design control and risk management documents that meet Quality Management System standards
  • Write, rewrite and/or edit technical documents such as technical procedure manuals, user manuals, programming manuals, service manuals, operational specifications, and related technical publications to communicate clearly and effectively technical specifications and instructions to a wide range of audiences.
  • Create manufacturing documentation for a variety of products and processes, including work Instructions, SOPs, flow charts and other work aids.
  • Meet and collaborate with scientists, quality, product management, and manufacturing to define and establish operational procedures and manuals for operational activities and tasks.
  • Write clearly and concisely to meet the needs of the target audience.
  • Prepare process flows, specifications, mockups.
  • Actively participate as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and other regulatory requirements.
  • Work with minimal supervision and manage time effectively.

Education/ Qualifications

  • Bachelor’s Degree in a science related field and 5+ years of technical writing experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.
  • Experience with ISO 9001, ISO 13485, and/or GMP environments.
  • Strong understanding of Design Control and Change Control.
  • Experience in writing scientific papers is preferred.
  • Excellent written and verbal communication skills.
  • Proficiency in MS Office.
  • Experience working in the regulated medical device industry.

Knowledge, Skills, Abilities:

  • Strong attention to detail and high regards for quality.
  • Able to write in explanatory and procedural styles for multiple end users.
  • Skilled at prioritization and multi-tasking in a self-driven, performance/results oriented, fast paced matrixed environment.
  • Must be highly collaborative: enjoys working in a diverse team and contributes to a positive work environment.
  • Understanding of FDA and international regulations, requirements, and guidances related to submissions, reporting, and document preparation
  • Ability to quickly translate complex processes \into easily understood writing, diagrams, and technical illustrations

Job Type: Full-time

Pay: From $36,000.00 per year

Benefits:

  • Insurance: Health, Dental, Life, Disability and Vision
  • 401(k) with  matching
  • Flexible spending account
  • Paid time off
Job Category: Research and Development
Job Type: Full Time
Job Location: Birmingham, AL