Principal Medical Writer, Scientific Publications - Oncology

About the position

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 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.
• Identifies and resolves conflicts, including document content issues.
• 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.
• 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.
• Performs literature searches as needed for drafting document content.
• Interprets literature information and makes recommendations for application to writing projects.
• Works with teams throughout the writing process, addresses questions/feedback, and drafts 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-AbbVie medical writers and external vendors/agencies.
• Recommends, leads, and implements tactical process improvements.

Requirements

• 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.
• Experience with Oncology/Hematology preferred.
• 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.
• 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.
• Excellent written and oral communication skills.
• Superior attention to detail.
• 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.

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