Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Summary
The Principal Medical Writer is responsible for providing writing support and advanced scientific writing expertise to the teams, 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 external groups to ensure accurate and timely completion/delivery of information and review of assigned writing projects. Serves as the scientific writing expert for the department.
Responsibilities
Serves as medical writing lead on more complex writing assignments. Works closely with in-function and cross-functional team(s) on document strategies. Implements all activities related to the preparation of writing projects.
Serves as a subject matter expert within department for assigned therapeutic/product areas.
Converts relevant data and information into a form that meets writing project requirements. Explains data in manner consistent with the target audience(s) and requirements for the project. Coordinates the review, approval, and other appropriate functions involved in the production of writing. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
Responsible for effective communication among project team members and contributors to assigned project. Communicates deliverables needed, writing process, and timelines. Holds team members and contributors 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 project 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 information 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, as needed for each writing project.
Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to writing projects.
Works with journal/congress throughout the writing process, addresses questions/feedback, as appropriate, and works with team to draft responses as necessary.
Maintains expert knowledge of US and international regulations, requirements and guidance associated with preparation of writing projects. Advises teams regarding compliance with guidelines or regulations. Learns and applies knowledge of therapeutic area and product to scientific publishing projects.
Serves as a department representative on project teams. Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments. Coaches, mentors, and assists more junior medical writers. Provides guidance to non-AbbVie medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.
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, publications, 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 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 project sand 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
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
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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