Summary:
Interprets, analyzes, writes, formats, and produces Clinical Development Documents, such as final Clinical Study Reports, abstracts, white paper reviews and regulatory agency submission documents on a given product or medical question across several therapeutic areas. Provides the basis of introductions/conclusions for production of reports for select medical literature. Works with various teams (both internal and external) involved in the clinical study or group generating the data to engage all parties who may contribute to writing sections of documents, review and/or approve to ensure final approved documents are generated according to planned timelines and function in the capacity of editor.
Primary responsibilities:
- Authors the first and subsequent drafts of clinical study reports from data generated from clinical studies, using ability to understand and interpret the data from tables and graphs and be able to place them in written and diagrammatic format with the medical/scientific perspective.
- Utilizes statistical and medical literature evaluation skills to compare data and potential citations for generation of these documents. Uses appropriate style, grammar, and flow and assumes responsibility for completeness, accuracy, and content of the prepared document.
- Organizes the material with co-authors, format, and co-ordinates processes for internal review and prepares the clinical report for final sign off. Ensures that the production of final report is according to departmental SOPs.
- Authors the 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.
- Provides authorship support to Medical Directors for protocol shells, updating the investigator brochures, annual safety reports and for regulatory documents such as sections of Biological License Applications to FDA and other regulatory agencies.
- Interfaces and assists the physicians, key opinion leaders that may be involved in preparing documents to provide editorial assistance.
- Assists publications planning team in integrating the science of Grifols products and relevant clinical study results into the strategic planning and execution of product publication.
- Ensures implementation of quality control (QC) and other critical quality aspects for final documents. Drives document production timelines according to established plans.
- Maintains 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 CT.gov, EU, and other worldwide website registries.
Additional responsibilities:
Accountable for worldwide registration and results disclosure of clinical studies. Oversees and supports processes for review and approval of new or updates of existing SOPs relevant to medical writing.
Knowledge, skills, & abilities:
Excellent scientific, technical and clinical studies knowledge. Excellent knowledge of MS Office, Viso, ISI Writer, Reference Manager, and medical/scientific search/retrieval tools. Excellent analytical, organizational, project management and communication (oral and written) skills. Ability to multi-task.
Requirements:
Bachelor's degree in science or related field with coursework in biology, pharmacy, or related areas. Advanced degree (MS, PhD, or PharmD) preferred.
Medical Writer 1: Typically requires 5 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD, equivalency is 2 years of pharmaceutical experience.)
Medical Writer 2: Typically requires 8 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD in statistics, equivalency is 5 years of pharmaceutical experience.)
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.
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. Must work with diverse groups to obtain consensus on issues.
#J-18808-Ljbffr
