Principal Medical Writer

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Write and edit high-quality, medically relevant AMCP dossiers for assigned therapeutics areas or assets to fulfill medical, scientific, and health economic objectives. Ensure successful preparation of high quality submission-ready documents and effective implementation of writing process and serve as AMCP dossier writing expert for the department.

Responsibilities:

• Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers
• Collaborate with therapeutic area leads to incorporate TA strategies, scientific platforms, value messages into AMCP dossier
• Collaborate with Global Medical Information to develop and/or edit responses to address specific unsolicited payer and health care provider requests for health outcome information
• Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance's and policies and procedures, and are used to appropriately respond to inquiries from payers and health care providers
• Provide medical writing support for multiple assets within a therapeutic area(s)
• Perform literature searches for drafting AMCP dossiers. Understand, assimilate, and interpret sources of information with appropriate guidance/direction from team members. Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify the results are consistent with study data
• Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines
• Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate
• Maintains awareness of current industry practices that pertain to Corporate Policies and Procedures. Must continually train/be compliant with all current industry and company requirements
• Complies with the reporting of adverse effects and product complaints to Pharmacovigilance and Surveillance

Qualifications

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, 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.
• Experience in the development of AMCP dossiers and documents related to outcomes research; understanding of model documents (templates) and how to use them correctly preferred.
• Proficient in managed care or access; previous experience in formulary or evidence-based evidence writing, review and assessments, and knowledge in evidence-based healthcare decision-making processes
• Ability to assimilate and interpret scientific content, and translate information for appropriate audience
• HEOR technical training is a plus
• Working knowledge of statistical concepts and techniques
• Highly proficient in the use of Microsoft WORD and POWERPOINT

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.