Remote Working Medical Writer 2
3 days left
- Experience Level
- Experienced (non-manager)
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.
● 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
● 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 the client's products and relevant clinical study results into the strategic planning and execution of
● Ensures implementation of quality control (QC) and other critical quality aspects for final documents. Drives document production timelines according to
● 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.
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.
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.
Work Location: RTP
Medical Writer I-Bachelor's degree in science or related field with coursework in biology, pharmacy, or related areas. Advanced degree (MS, PhD, or PharmD)
Plus 5 years of pharmaceutical experience in clinical research/medical writing. (If PhD, equivalency is 2 years of pharmaceutical experience.)
Medical Writer II- Medical Writer I-Bachelor's degree in science or related field with coursework in biology, pharmacy, or related areas. Advanced degree (MS, PhD,
or PharmD) preferred.
Plus 8 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD in statistics, equivalency is 5 years of
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
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
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