Senior Medical Writer, Scientific Publications

Summary

Join AbbVie as a Senior Medical Writer and contribute to the development of innovative medicines and solutions. You will be responsible for leading medical writing projects, ensuring high-quality documentation, and collaborating with cross-functional teams. This role requires strong medical writing expertise, experience in the healthcare industry, and a deep understanding of US and international regulations. You will be working remotely anywhere in the U.S. and will have the opportunity to mentor junior medical writers and external vendors.

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

• The Senior Medical Writer is responsible for providing medical writing, 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 cross-functional groups to ensure accurate and timely completion/delivery of information and review of writing projects
• Serves as medical writing lead on assigned projects
• Works closely with in-function and cross-functional team(s) on project strategies
• Implements all activities related to the preparation of writing projects
• Coordinates the review, approval, and other appropriate functions involved in the production of writing projects
• Arranges and conducts review meetings with the team
• Ensures required documentation is obtained
• Converts relevant data and information into a form that meets project requirements
• Explains data in manner consistent with the target audience(s) requirements
• Effectively communicates deliverables needed, writing process, and timelines to team members
• Holds team members accountable to agreed-upon project dates and with an appropriate quality level
• Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate
• Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams
• Interprets and explains data generated from a variety of sources
• Verifies that results are consistent with protocols
• Challenges conclusions when necessary
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project following applicable divisional guidelines, templates, and SOPs
• Performs literature searches as needed for drafting document content
• Interprets literature information and makes recommendations for application to writing project
• Works with journal/congress throughout the writing process, addresses questions/feedback, as appropriate, and works with team to draft responses as necessary
• Knowledgeable of US and international regulations, requirements and guidance associated with preparation of writing projects
• Learns and applies knowledge of therapeutic area and product to writing projects
• Must continually train/be compliant with all current industry requirements as they relate to assigned projects , including submission/approval standards
• Serves as a representative on project teams
• Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments
• May mentor and provide guidance to more junior medical writers and/or external vendor/agencies
• Implements 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

• Employee can work remotely anywhere in the U.S
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• This job is eligible to participate in our short-term incentive programs
• This job is eligible to participate in our long-term incentive programs