The Principal Medical Writer is responsible for providing scientific publications and advanced scientific writing expertise to the clinical pharmacology teams, ensuring 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. DMPK, Statistical Support, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications. Serves as the scientific writing content expert for the department.
Serves as medical writing lead on more complex scientific publications for clinical pharmacology, including Phase 1 studies, population pharmacokinetics and exposure-response modeling . Works closely with the Publications team 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. 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. 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. 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. Ensures all 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 or clinical regulatory documents. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. 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. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). Coaches, mentors, and assists medical writers. Provides guidance to non-Abbott medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.
Level will be based on education and years of experience. Qualifications:
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- 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.
- 2 years relevant industry experience preferred 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..
- 4 years experience in experimental design and clinical/preclinical data interpretation preferred.
- High-level content writing experience and experience with all types of clinical publications 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 requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
- 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.
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