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 .

Purpose :

The Principal Medical Writer is responsible for providing scientific publications support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g. Medical Affairs, PK, Statistical Support, Data Management, Clinical) to ensure accurate and timely completion/delivery of information and review of scientific publications. Serves as the scientific writing content expert for the department.

Therapeutic Areas : Immunology, Neuro and Oncology

Responsibilities :

• Serves as medical writing lead on more complex scientific publications Works closely with the Publications teammates on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts)
• Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.
• Converts relevant data and information into a form that scientific and business objectives. Explains data in manner consistent with the target audience(s) and journal/congress requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
• Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
• Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info 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 per journal/congress, ICH and other governing bodies 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 scientific publications
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications. Advises teams regarding compliance with scientific publications as defined in journal/congress guidelines or regulations. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant

• Serves as a department representative on project teams. Coaches, mentors, and assists medical writers. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.

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), ISMPP 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.
• High-level content writing experience and experience with all types of scientific publications. 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 scientific publications and submissions and ability to advise teams regarding compliance with regulations. Expert knowledge of current electronic document management systems and information technology.
• Excellent written and oral communication skills. 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.
• Extensive experience in working with collaborative, cross-functional teams, including project management experience.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
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.