Principal Medical Writer

Summary

Join AbbVie as a Principal Medical Writer and contribute your advanced scientific writing expertise to support various teams. You will be responsible for leading complex writing assignments, ensuring high-quality documents, and collaborating with cross-functional teams. This remote position requires a Bachelor's degree in a relevant field and significant writing experience, with a preference for a Master's or PhD and oncology/hematology experience. You will be a subject matter expert, interpreting data, and ensuring compliance with regulations. AbbVie offers a comprehensive benefits package including paid time off, health insurance, and participation in short-term and long-term incentive programs.

Requirements

• Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience
• 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
• 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

Responsibilities

• Serve as medical writing lead on more complex writing assignments
• Work closely with in-function and cross-functional team(s) on document strategies
• Implement all activities related to the preparation of writing projects
• Serve as a subject matter expert within department for assigned therapeutic/product areas
• Convert relevant data and information into a form that meets writing project requirements
• Explain data in manner consistent with the target audience(s) and requirements for the project
• Coordinate the review, approval, and other appropriate functions involved in the production of writing
• Arrange and conduct review meetings with the team
• Ensure required documentation is obtained
• Be responsible for effective communication among project team members and contributors to assigned project
• Communicate deliverables needed, writing process, and timelines
• Hold team members and contributors accountable to agreed-upon project dates
• Negotiate with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.)
• Identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals
• Understand, assimilate, and interpret sources of info with appropriate guidance/direction from project teams and/or authors
• Interpret and explain data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables
• Verify that results are consistent with protocols
• Confirm completeness of information to be presented
• Challenge conclusions when necessary
• Independently resolve document content issues and questions
• Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project
• Perform literature searches as needed for drafting document content
• Interpret literature information and make recommendations for application to writing projects
• Work with publication strategy leads and cross-functional partners throughout the writing process, address questions/feedback, as appropriate, and work with team to draft responses as necessary
• Maintain expert knowledge of US and international regulations, requirements and guidance associated with preparation of writing projects
• Advise teams regarding compliance with guidelines or regulations
• Learn and apply knowledge of therapeutic area and product to scientific publishing projects
• Serve as a department representative on project teams
• Act as Subject Matter Expert regarding computer-based technologies utilized by the respective departments
• Coach, mentor, and assist more junior medical writers
• Provide guidance to non-AbbVie medical writers and external vendors/agencies
• Recommend, lead, and implement tactical process improvements, both within the department and division-wide

Preferred Qualifications

• 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
• 2 years relevant industry experience preferred
• 4 years experience in experimental design and clinical/preclinical data interpretation preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs