Senior Medical Writer
Orange County Metro Area, CA
Bachelor of Science with 6-10 years industry medical writing experience; or Bachelor's degree in English or communications with relevant science experience with 6-10 years industry medical writing experience; or Masters of Science with 3-6 years of industry medical writing experience; or Doctoral degree with 2-4 years of industry medical writing experience.
Gastroenterology, Neurology, Eye care, or Facial Aesthetics
Senior Medical Writer Scientific Publications and Planning
Responsible for assisting authors in the writing of scientific publications and effective implementation of the publications writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with multiple functional groups (eg, PK, Statistics, Health Outcomes) to ensure accurate and timely completion/delivery of publications.
A Senior Medical Writer would be expected to work on publications that require in-depth product and scientific knowledge. Senior Medical writers should have a good working knowledge of biostatistics.
Other activities, special projects, and assignments may be given. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects, and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures
Writes and edits the content of scientific abstracts, posters, and manuscripts supportive of business and scientific objectives, with direction and/or guidance on medical data interpretation, publication strategy, and statistical data analysis from the PPT and external authors, as appropriate. Adhere to standardized publication processes and SOP requirements for all publishing projects. Coordinate the review, approval, submission, and production of publishing projects.
3 years of 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.
Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
Working knowledge of current electronic document management systems and information technology.
3 years of experience in experimental design and clinical/preclinical data interpretation preferred.
Knowledge of biostatistics preferred.
American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.