Medical Writer

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions.

Key Responsibilities:

• Author clinical study reports from data generated from clinical studies, utilizing the ability to understand and interpret data from tables and graphs, and placing them in written and diagrammatic format with a medical/scientific perspective.
• Utilize statistical and medical literature evaluation skills to compare data and potential citations for generation of these documents, using appropriate style, grammar, and flow, and assuming responsibility for completeness, accuracy, and content of the prepared document.
• Organize material with co-authors, format, and coordinate processes for internal review, and prepare the clinical report for final sign off, ensuring that the production of the final report is according to departmental SOPs.
• Author first and subsequent drafts of documents or abstracts/posters from data from clinical studies or other sources, such as drug safety, or from published sources.
• Provide authorship support to Medical Directors for protocol shells, updating investigator brochures, annual safety reports, and for regulatory documents, such as sections of Biological License Applications to FDA and other regulatory agencies.
• Interface and assist physicians and key opinion leaders in preparing documents to provide editorial assistance.
• Assist publications planning teams in integrating the science of Grifols products and relevant clinical study results into strategic planning and execution of product publication.
• Ensure implementation of quality control (QC) and other critical quality aspects for final documents, driving document production timelines according to established plans.
• Maintain Clinical Study Registry and Results Disclosure, within current worldwide regulations, interfacing and uploading clinical protocol registration data and clinical study report disclosure data to FDA, EU, and other worldwide website registries.

Requirements:

• Bachelor's degree in science or related field with coursework in biology, pharmacy, or related areas. Advanced degree (MS, PhD, or PharmD) preferred.
• Typically requires 5 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD, equivalency is 2 years of pharmaceutical experience.)
• Typically requires 8 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD in statistics, equivalency is 5 years of pharmaceutical experience.)

Occupational Demands:

• 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.