Senior Medical Writer

Summary

Join AbbVie as a Senior Medical Writer and lead medical writing projects, collaborating with cross-functional teams to produce high-quality documents. You will be responsible for coordinating reviews, interpreting data, and ensuring compliance with regulations. This remote position offers multiple openings across various therapeutic areas. A Bachelor's degree and 3 years of relevant experience are required, with an advanced degree and AMWA certification preferred. AbbVie provides 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 relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience
• 3 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
• Knowledgeable of US and international regulations, requirements and guidance associated with preparation of assigned writing projects
• Knowledge and experience working with templates and relevant systems
• Excellent written and oral communication skills
• Experience in working with collaborative, cross-functional teams, including project management experience
• Ability to assimilate and interpret scientific content and translate information for appropriate audience
• Superior attention to detail
• Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy
• Expert in word processing, flow diagrams, and spreadsheets
• Excellent working knowledge of software programs in Windows environment

Responsibilities

• Serve as medical writing lead on assigned projects
• Work closely with in-function and cross-functional team(s) on project strategies
• Implement all activities related to the preparation of writing projects
• Coordinate the review, approval, and other appropriate functions involved in the production of writing projects
• Arrange and conduct review meetings with the team
• Ensure required documentation is obtained
• Convert relevant data and information into a form that meets project requirements
• Explain data in a manner consistent with the target audience(s) requirements
• Effectively communicate deliverables needed, writing process, and timelines to team members
• Hold team members accountable to agreed-upon project dates and with an appropriate quality level
• Negotiate with functional areas on project outcomes and deliverables to meet conflicting demands
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate
• Understand, assimilate, and interpret sources of information with appropriate guidance/direction from development teams
• Interpret and explain data generated from a variety of sources
• Verify that results are consistent with protocols
• Challenge conclusions when necessary
• Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project following applicable divisional guidelines, templates, and SOPs
• Perform literature searches as needed for drafting document content
• Interpret literature information and make recommendations for application to writing project
• Work with journal/congress throughout the writing process, address questions/feedback, as appropriate, and work with team to draft responses as necessary
• Be knowledgeable of US and international regulations, requirements and guidance associated with preparation of writing projects
• Learn and apply knowledge of therapeutic area and product to writing projects
• Continuously train/be compliant with all current industry requirements as they relate to assigned projects, including submission/approval standards
• Serve as a representative on project teams
• Act as Subject Matter Expert regarding computer-based technologies utilized by the respective departments
• Mentor and provide guidance to more junior medical writers and/or external vendor/agencies
• Implement tactical process improvements

Preferred Qualifications

• Advanced degree preferred
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical
• 3 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
• Employees can work remotely anywhere in the U.S