Offer summary

Qualifications:

Bachelor's degree in a technology or communications field, or equivalent experience., 1-3 years of experience in technical writing in an FDA-regulated environment., Proficient in MS Word, Excel, PowerPoint, and Outlook, with knowledge of Gitlab, Confluence, Loop, and Veeva., Strong verbal and written communication skills, with the ability to establish working relationships across teams..

Key responsibilities:

Design, develop, and update required technical documentation for software products.

Document programming standards and procedures, and assist with editing quality documents to ensure regulatory compliance.

Capture development team activities in the form of requirements and technical documentation.

Notify manager of workflow status, incorporate team comments, and follow up on review and approval processes.

Job description

About Sequel

Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

Job Overview

Sequel Med Tech is seeking a CONTRACT Technical Writer to support our rapidly growing software product portfolio. Contract will be 3-6 months with possibility to extend. The successful candidate will utilize their strength as a communicator to serve as a technical translator, distilling engineering and healthcare concepts for a variety of technical and non-technical audiences. Working alongside the Product Managers, the Technical Writer will be responsible for capturing development team activities in the form of requirements, technical documentation, and Quality Management records. If you’ve been looking for a way to combine your technical acumen and liberal arts foundation into a role where you are making a meaningful impact for the world, come join us in defining the future of diabetes management.

Job Responsibilities and Essential Duties

Responsible for designing, developing, and updating required technical documentation.
Responsible for technical writing/editing for all types of documentation produced within a modern software development environment.
Utilize knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
Document programming standards and procedures. Track and review change control documentation.
Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.
Review current documents- incorporate comments from Manager. Navigate through Veeva (Documentum) system utilizing current templates.
Notify manager of workflow status and issues.
Incorporate comments from team members and provide status to manager on review and approval workflow. Follow up with team members on comments.

Minimum Requirements

Education:
Bachelor's degree in a technology or communications field, or equivalent experience

Years of Experience:
1 - 3 Years of experience in technical writing in an FDA-regulated environment

Required Knowledge, Skills and Abilities

Technical writing abilities and good time management.
Strong root cause analysis skills with experience regarding quality standards.
Be able to establish working relationships with other support and production areas in order to gather all the necessary information required.
Working knowledge of Gitlab, Confluence, Loop, Veeva.
Proficient in MS Word, Excel, PowerPoint and Outlook.
Interact well with a diverse group of individuals.
Self-motivated and willing to be proactive in resolving issues.
Excellent Verbal and written communication skills.
Experience collaborating with functional (Quality, Legal, Marketing, etc.) partners to navigate functional gatekeepers. 
Bias towards active collaboration over working in silos and throwing over the wall.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions
Use of computer and telephone equipment and other related office accessories/devices to complete assignments
May work extended hours during peak business cycles
Physical requirements such as lifting specific weights

Required profile