For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols' three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
Develop, design, & control instructional & informational tools needed to assure safe, appropriate, & effective use of science & technology, intellectual property, & manufactured products & services. Combine multimedia knowledge & strong communication skills w/ technical expertise to educate across the entire spectrum of users' abilities, technical experience, & visual & auditory capabilities.
Primary responsibilities for role:
Design & implement work instructions, area guidelines, knowledge base topics, & departmental SOPs as required.
Attend regular project/core team meetings as required as an Operations extended core team representative
Create new documentation & improve existing documentation
Initiate, edit, review & approve document changes.
Work w/ key personnel to exp& knowledge & understanding of how to perform & troubleshoot manufacturing processes, instrumentation, assays, software, etc. in order to develop & improve content.
Identify & implement document changes to maintain consistency across product lines/processes.
Lead collaborative review sessions.
Manage multiple user documentation projects at a time.
Assist core team members & project team leads in the developing documentation timelines & deliverables.
Work w/ translation vendors in managing translation development & procurement process.
Contribute to work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs.
Revise existing documentation by working w/ stakeholders, partners, or distributors to facilitate revision, review, & approval of documentation.
Coordinate the collaborative review process & establish review & edit cycles.
Coordinate the transition of documentation through development, pilot & production phases as appropriate.
Through Technical Training, maintain & exp& knowledge of manufacturing processes, assays, instrumentation, & software as it applies to documentation.
Coordinate final production of documents w/ print vendors as required. Reagent Process Transfer
Maintain & monitor the development document system as required. Act as Document Owner for Development Documents (to include MSDSs).
Provide support for the development document system.
Act as Document Owner for documentation CCRs & route documents through the document change control process, Support other Document Owners by creating change lists, including all necessary supporting justifications for changes & compiling accurate & complete documentation packages, Contribute to work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs, W/ direction, work closely w/ other technical writers & stakeholders to develop & produce documents, Assist in the development & revision of documents, following established style & format guidelines, Proofread & review documents, Rely solely on other Technical Writers or supervisor to manage projects & timelines.
Knowledge, Skills, and Abilities:
Communication Skills, Detail Orientation, Organizational Skills, Learning, Teamwork, Beginning Technical Writing Theory & Practices
4 year degree required; preferably in technical writing
Experience working in a regulated, ISO or GMP environment in healthcare or biotech industry.
Minimum 4 years of experience in technical writing and editing user software or hardware instructions.
Advanced proficiency in Adobe Suites program, experience must be current and used in a professional setting
Experience with DCM is preferred.
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 and InDesign is 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.
Demonstrated ability to work independently, according to strict schedules, and in a team environment.
Demonstrated ability to identify areas for improvement and provide solutions.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, &/or lift, carry, push, pull or otherwise manipulate objects of a
negligible weight frequently or continuously. Sedentary work involves sitting the majority of time. Jobs are sedentary if walking & st&ing are required only
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at ~~~
Req ID: 73782
Type: Regular Full-Time
Job Category: Regulatory Affairs