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.
Applies advanced knowledge of principles, concepts and industry practices and standards in the area of developing and writing material for technical publications. Develops and writes procedures, process descriptions, forms, job aids, directives, policies, work instructions, and training materials for review and approval, ensuring that completed publications meet or exceed customer and company specifications for technical content and accuracy.
- Observes production, developmental and experimental activities to determine operating procedures and details. Facilitates validation activities for procedures with the assistance of subject matter experts. Interviews personnel and reads related material to become familiar with technologies, practices and production methods.
- Reviews manufacturer’s instructions, drawings, sketches, parts lists, specifications, products and equipment to integrate and delineate technology, operating procedure, sequence and detail. Selects photographs, drawings, sketches, diagrams, and charts to illustrate material.
- Reviews published materials and recommend revisions or changes in scope, format, and content. Assists Document Control Manager as needed in the development and implementation of processes, procedures and special projects.
- Assists the Director, Regulatory Affairs in the preparation, proofreading, editing, and assembling of final submission documents critical to the approval of standard operating procedures.
- Coordinates and chairs ad-hoc committees for document revisions. Conducts training on Document Control related topics. Provides guidance, assistance and support to subject matter experts and others assigned to write or revise procedures in accordance with cGMP good documentation practices.
- Recommendations by the Technical Writer influence others by impacting the style and language used in standard operating procedures, as well as by impacting their scope and content. Compliant, effective processes profoundly rely on the procedures that define them. Decisions made by the technical writer to include or exclude process steps, illustrations, and other details in a procedure, or other technical document, can significantly impact compliance, process efficiency, and process productivity.
Experience and Education
- Bachelor’s Degree in related field.
- Typically requires 5 years of related experience in an Food Drug Administration regulated environment; Source Plasma preferred. Field related certification a plus.
- Knowledge of plasma industry practices and regulations. Strong knowledge and understanding of FDA requirements for good documentation practices. Excellent oral and written communication skills. Excellent interviewing, listening, and observation skills in order to obtain the information needed to fully grasp and document a process. Demonstrated competence with Microsoft Word, Excel, PowerPoint, Visio, and database applications required. Ability to work long hours at the computer. Ability to work independently and collaboratively with all levels of leadership. Demonstrated ability to organize work, keep comprehensive substantiating records. Ability to prioritize competing tasks and meet deadlines. 30-50% travel required; extensive travel for projects as necessary.
- Occupational Demands Form # 9: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
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