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Job Details

Technical Writer II Job

Company name
Grifols S.A.

Location
Emeryville, CA

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Profile

This position will provide technical writing and administrative services in support of instrument and software operator manuals, product inserts, labels, specifications, and training materials.

Major Activities:

Provide technical writing and administrative services in support of instrument and software operator manuals, product inserts, labels, specifications, and training materials:

Write and edit documents to support Labeling Development in compliance with ISO, cGMP, and FDA guidelines, working within established formats and templates. Document types include: specifications, SOPs, package inserts, guides, and instrument and software manuals.

Identify areas for improvement (e.g., processes, styles, formats), and execute continuous improvement initiatives.

Maintain a high level of quality, clarity, and consistency for all documents.

Organize and maintain department files, databases, and spreadsheets.

Represent Labeling on core teams and coordinate with project teams to determine project and document requirements.

Conduct interviews with subject matter experts in order to gather data and understand scope, requirements, risk mitigations, etc.

Keep track of documentation through the entire development process while adhering to strict timelines, maintaining revision control, maintaining change lists, and managing reviewers.

Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.

Process documents through the electronic documentation control system (Livelink).

Manage translation projects with translation vendor and perform translation reviews for consistency with formatting and layout.

Key Performance Indicators:

Keep track of documentation through the entire development process while adhering to timelines, maintaining revision control, maintaining change lists, and managing reviewers. 

Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.

Job Requirements:

Education:

Bachelor's degree preferably in English or Technical Communication, or Certificate in Technical Writing.

Experience/Professional requirement:

Minimum one year of experience writing and editing user software or hardware instructions.

Advanced proficiency in Adobe FrameMaker and Microsoft Word. FrameMaker experience must be current and used in a professional setting. Proficiency in Illustrator, Excel, PowerPoint. Mapcap Flare a plus.

Excellent written, oral communication, and editorial skills.

Familiarity with Chicago Manual of Style and technical writing standards.

Strong interpersonal skills; ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules.

Experience working in a regulated, ISO or GMP environment. Experience with EDMS and workflows a plus.

EEO Minorities/Females/Disability/Veterans

Job Criteria:

Start Date: ASAP

Position Type: Full-Time Permanent

Years of Experience Required: 1

Education Required: Bachelors

Overnight Travel:

Vacation Time:

Company Profile:

Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

Company info

Grifols S.A.
Website : https://www.grifols.com

Company Profile
We are a global healthcare company with more than 75 years of history improving the health and well-being of people around the world. We produce essential plasma medicines for patients and provide hospitals, pharmacies, and healthcare professionals with the tools, information, and services they need to efficiently deliver expert medical care. We are present in more than 100 countries, with global headquarters in Barcelona, Spain, where the company was founded. We are the world leader in plasma collection, with a network of 160 donation centers in the U.S., and a leading producer of plasma medicines used to treat rare, genetic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, we offer a comprehensive portfolio of products designed to support safety from donation through transfusion.

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