Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Principal Medical Writer is responsible for providing scientific publications or clinical regulatory document 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. The Prinicipal Medical Writer provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. The Prinicipal Medical Writer serves as a scientific writing content expert for the department and actively contributes to process improvement activities.
Responsibilities:
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Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents.
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Serves as a department representative on project teams. Serves as a subject matter expert within department for assigned therapeutic/product areas. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. COSMOS, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers. Implements tactical process improvements.
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Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is completed.
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Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively.
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Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with all current industry requirements as they relate to scientific publications or clinical regulatory submissions, including electronic submission/approval standards.
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Responsible for effective communication to 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.). Identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
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Understands, assimilates, and interprets sources of info Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
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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.
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Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process. Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary.
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Recommends and implements tactical process improvements. Participates in process improvement activities.
Qualifications
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Bachelor's degree in English or Communications with relevant science expertise or Bachelor's degree in Life Science with relevant writing expertise. Advanced degree and/or professional certification/credentials preferred.
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3-4 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.
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American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
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High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
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Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations. Knowledge and expertise with Common Technical Document content templates. Expert knowledge of current electronic document management systems and information technology.
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Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. Experience in working with collaborative, cross-functional teams, including project management experience.
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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 thisposting 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 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 anduntil 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
