Exact Sciences
Senior Technical Writer
This job is now closed
Job Description
- Req#: R23-2864
- Managing projects to create and evolve documentation by hosting meetings with regulatory, quality, document users, and subject matter experts (SMEs).
- Acting as a mentor and resource to other technical writers, including reviewing documentation and providing editing suggestions.
- Creating educational materials and hosting workshops for other departments across Exact Sciences.
- Engaging with internal departments as a consultant and supporting document creation and evolution.
- Engaging with internal departments and seeking to understand their documentation gaps and needs.
- Creating, adapting, and following project schedules and deadlines.
- Leading effective pre-review of draft documents with subject matter experts (SMEs) and reconciling comments to ensure accuracy and usability.
- Partnering with cross-functional SME representatives from Technical Services, Regulatory Affairs, Quality, Systems Development, Operations, Research & Development (R&D), Exact Sciences Laboratories, Metrology, Instrument Production, Sustaining Engineering, and others as required to obtain an in-depth understanding of the product, the audience, and the documentation requirements.
- Working collaboratively with document users and SMEs and owning the creation and evolution of applicable documentation.
- Determining the clearest and most logical way to present information and instructions for greatest reader comprehension; write and edit technical information accordingly.
- Creating and/or applying graphics and illustrations to support written content, increase users’ understanding, elaborate on, or complement technical writing.
- Producing high-quality documentation that meets applicable standards and is appropriate for the intended audience.
- Writing, revising, editing, or updating instructions, technical information, and frequently asked questions, as necessary to aid users in performing a complex process without prior knowledge.
- Remaining current on product developments and document requirements.
- Ability to deliver high quality documentation with attention to detail.
- Ability to quickly grasp complex technical concepts and make them easily understandable in text and images.
- Ability to write in explanatory and procedural styles for multiple audiences.
- Excellent written skills in English.
- Strong time management skills including prioritization.
- Excellent organizational skills including aptitude in multi-tasking.
- Strong verbal communication and ability to collaborate cross functionally.
- Upholding company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Supporting and complying with the company’s Quality Management System policies and procedures.
- Ability to maintain regular and reliable attendance.
- Ability to work designated schedule.
- Ability to lift up to 10 pounds for approximately 5% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability and means to travel between Exact Sciences locations.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
- Bachelor’s Degree in Biotechnology, Engineering, Technical Communications, or field as outlined in the essential duties; or High School Degree/General Education Diploma (GED) and 4 years of relevant experience as outlined in the essential duties in lieu of Bachelor’s Degree.
- 7+ years of technical writing experience in an engineering or biotechnology field.
- 3+ years of experience working within a regulated document control environment.
- 2+ years of experience working in an equipment/hardware technical writing position.
- Proficiency in Microsoft Office programs.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Ability to author documents to comply with ISO 13485 and 21 CFR 820 regulations.
- Familiarity with Agile Product Lifecycle Management software.
Position Overview
The Senior Technical Writer is responsible for creating and modifying technical documents related to instruments and automation such as service procedures, user and service manuals, and training materials. The Senior Technical Writer is also responsible for creating and modifying technical documents related to test platforms and products, such as standard operating procedures (SOPs), study protocols, reports, and customer notifications. This role will compose clear technical documentation to explain complex information in a clear and concise manner and partner with engineering staff and scientists to ensure accuracy of process descriptions. The Senior Technical Writer leads documentation projects to ensure regulations and user needs are met.
Essential Duties
Include, but are not limited to, the following:
Minimum Qualifications
Preferred Qualifications
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Salary Range:
$82,000.00 - $130,000.00If you require a reasonable accommodation with the application process, please email hr@exactsciences.com .
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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About the company
Exact Sciences Corp. is a molecular diagnostics company with an initial focus on the early detection and prevention of colorectal cancer.
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