Abbott Laboratories - Plano, TX

posted 3 months ago

Full-time - Mid Level
Plano, TX
10,001+ employees
Miscellaneous Manufacturing

About the position

Abbott is seeking a Technical Writer II to join our team in Plano, TX. This role is crucial in supporting the development and launch of our medical devices by creating clear and concise documentation for both clinicians and patients. The Technical Writer will work under general supervision to research, write, and edit various manuals and instructions for use, ensuring compliance with regulatory submissions and product launches. The successful candidate will collaborate with cross-functional teams, including development engineering, marketing, regulatory affairs, and clinical engineering, to ensure that all documentation is accurate and complete. This position requires a strong understanding of the company's products, markets, and regulatory requirements, as well as the ability to communicate effectively across multiple levels of the organization. In this role, you will be responsible for writing, editing, and formatting a wide variety of product manuals while adhering to Abbott's Quality Assurance policies and both domestic and international regulatory requirements. You will recommend the overall organization and layout of documents, develop publication concepts for effective communication, and coordinate with graphic design and production personnel to meet publication schedules. Additionally, you will lead projects aimed at implementing new technologies and improving departmental processes, requiring collaboration with other functional groups. Staying current on developments in the medical device field and maintaining compliance with FDA regulations and company policies will be essential to your success in this position. The Technical Writer II will also support all company initiatives as identified by management, contributing to the Quality Management Systems (QMS) and Environmental Management Systems (EMS). This role is ideal for someone who is highly organized, detail-oriented, and capable of managing multiple projects simultaneously in a fast-paced environment.

Responsibilities

  • Research, write, and edit clinician-facing and patient-facing instructions for use and other manuals.
  • Collaborate with development engineering, marketing, regulatory affairs, and clinical engineering personnel to ensure accuracy and completeness of documentation.
  • Recommend overall organization and layout, mode of presentation, publication methods, and related matters.
  • Develop publication concepts for effective communication of subject matter.
  • Coordinate with graphic design, translation, and production personnel to meet publication schedules.
  • Lead projects to implement new technology for Medical Device Documentation and Localization (MDDL).
  • Lead projects to improve departmental processes requiring cooperation from other functional groups.
  • Troubleshoot existing processes and technologies.
  • Remain current on developments in the company's products, markets, policies, and objectives, including regulatory requirements and restrictions.
  • Support all Company initiatives as identified by management in support of Quality Management Systems (QMS) and Environmental Management Systems (EMS).
  • Comply with U.S. Food and Drug Administration (FDA) regulations and other regulatory requirements.

Requirements

  • Bachelor's Degree in a relevant technical discipline, Communications, Marketing, English (or equivalent) OR an equivalent combination of education and experience.
  • Minimum of 3 plus years of progressively more responsible experience as a technical writer in a medical or high technology (preferably biotechnology) environment.
  • Comprehensive written and verbal communication, interpersonal, presentation, analytical, and project management skills.
  • Ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
  • Highly organized and attentive to detail.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Nice-to-haves

  • Advanced degree
  • Experience working in a broader enterprise/cross-division business unit model.

Benefits

  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO
  • Excellent retirement savings plan with high employer contribution
  • Tuition reimbursement
  • Freedom 2 Save student debt program
  • FreeU education benefit - an affordable path to getting a bachelor's degree
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