The remote Principal Medical Writer is responsible for providing clinical regulatory document support 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/devices and/or projects within various therapeautic areas (oncology and aesthetics highly preferred, immunology preferred). 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 clinical regulatory submissions. Serves as the scientific writing content expert for the department.
Serves as medical writing lead on more complex clinical regulatory documents, such as those associated with filings and dossiers. Works closely with the Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
Serves as a subject matter expert within department for the Aesthetics area. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. 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 meets clinical regulatory document requirements. Explains data in manner consistent with clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. 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 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 clinical regulatory documents.
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.
Maintains expert knowledge of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions. Advises teams regarding compliance with clinical regulatory document content as defined in regulations. Must continually train/be compliant.
Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, ARCH, and eCTD databases). Coaches, mentors, and assists 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.
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. Clinical regulatory device writing experience preferred.
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 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.
Expert knowledge of US and international regulations, requirements, and guidance associated with 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. Knowledge of Medical Device Regulation (MDR) preferred.
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.