Job Abstract

Kelly FSP Science and Clinical is currently seeking a Technical Writer 1 for a long-term engagement with one of our Global Pharmaceutical clients. This position is onsite 2-3 days per week in Irvine, CA. Please let me know if this is a position of interest to you and we can schedule a call to discuss this opportunity!

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

General Purpose:

Reports to the TW 4 or higher. Support Engineers with preparing, technical documents and manuals, explain complex information in a clear and concise manner and working with scientific staff to ensure accuracy of product descriptions. Responsible for documenting and managing change requests and ECO’s to ensure complete traceability in a compliance environment.

Duties And Responsibilities:

Writes and/or edits technical materials such as reports of research findings, regulations in technical areas, technical manuals, specifications or scripts on technical subjects. Provides written and oral reports, abstracts, summaries, charts, graphs, or other products.

Develops information and analysis to select and present information on the specialized subject in a format and at a level suitable for the intended audience.

Analyzes and review the preparation and organization of complex research.

Prepares written documents, including reports, articles, formal proposals, memoranda, and formal correspondence.

Edits reports and assists in or directs the development and presentation of the information.

Analyzes changes to various projects and prepares reports of changes for review.

Organizes and coordinates assignments that involve complex, novel or obscure problems and/or special requirements for analyzing and organizing information.

Lead and/or participate in the development of new documents or update existing documentation used for new product development

Participate in the development and maintenance of document standards, naming/numbering conventions, and templates for procedures, work instructions, and other relevant document types

Support/manage document workflow and ensure compliance

Ensure that document reviews and approvals are managed in an efficient and effective manner

Assist in the identification and removal of old/obsolete procedures and work instructions, as required

Collaborate within department and cross-functionally to meet set objectives and execute against manufacturing schedule.

Performs other related duties as assigned

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

Education/Training/Experience:

Bachelor’s degree

Minimum 2 years in a similar position.

Technical writing knowledge in the medical device industry, preferably

Prior experience using word processing, spreadsheet, and presentation software

Excellent written and verbal communication skills, possess a strong sense of responsibility and urgency

Strong process improvement mindset; passion for quality

Demonstrated effective interpersonal and effective teamwork skills

Analytical & problem-solving skills/root-cause analysis

Strong organizational skills with high attention to detail

Practical knowledge of project management, preferably

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