Medical Writer

Title: Principal Medical Writer

Duration: 12+ month contract

Location: Remote | Based in IL

Summary

The Principal Medical Writer is responsible for providing writing support and advanced scientific writing expertise to the teams, ensuring successful preparation of high quality documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups to ensure accurate and timely completion/delivery of information and review of assigned writing projects. Serves as the scientific writing expert for the department.

Responsibilities

• Serves as medical writing lead on more complex writing assignments. Works closely with in-function and cross-functional team(s) on document strategies. Implements all activities related to the preparation of writing projects.
• Serves as a subject matter expert within department for assigned therapeutic/product areas.
• Converts relevant data and information into a form that meets writing project requirements. Explains data in a manner consistent with the target audience(s) and requirements for the project. Coordinates the review, approval, and other appropriate functions involved in the production of writing. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
• Responsible for effective communication among project team members and contributors to assigned project. Communicates deliverables needed, writing process, and timelines. Holds team members and contributors accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, and generate innovative ways to ensure teams achieve project goals.
• Understands, assimilates, and interprets sources of info with appropriate guidance/direction from project teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of information to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project.
• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to writing projects.
• Works with authors throughout the writing process, addresses questions/feedback, as appropriate, and works with team to draft responses as necessary.
• Maintains expert knowledge of US and international regulations, requirements, and guidance associated with preparation of writing projects. Advises teams regarding compliance with guidelines or regulations. Learns and applies knowledge of therapeutic area and product to scientific publishing projects.
• Serves as a department representative on project teams. Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments. Coaches, mentors, and assists more junior Medical Writers. Provides guidance to non-Company Medical Writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.

Qualifications

• Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience.
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
• 4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D.
• 2 years relevant industry experience preferred.
• 4 years’ experience in experimental design and clinical/preclinical data interpretation preferred.
• High-level content writing experience and experience with all types of writing projects. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
• Expert knowledge of US and international regulations, requirements and guidance associated with preparation of assigned writing projects and ability to advise teams regarding compliance with regulations. Expert knowledge and experience working with templates and relevant systems.
• Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
• Extensive experience in working with collaborative, cross-functional teams, including project management experience. Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.