Technical Writer II

Location: 

CA-San Diego, US

Contract Type:  Regular Full-Time
Area:  Regulatory Affairs
Req Id:  388527

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

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

 Primary Responsibilities for Role:

● Provide technical writing and administrative services in support of instrument and software operator’s 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 in all documents.

● Organize and maintain department files, databases, and spreadsheets.

● Represent Labeling in 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 mitigation, etc.

● Keep track of documentation through the entire development process while adhering to strict timelines maintaining revision control and 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 management system (Documentum).

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

Education:

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

Experience:

• Minimum two years of experience writing and editing user software/hardware instructions.

• 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 working with electronic document management systems and workflows.

Equivalency:

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.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

 

Learn more about Grifols

 


Nearest Major Market: San Diego