Do you have experience with scientific research and/or medical writing in the life sciences industry? Do you have a passion for project management and error-free deliverables? If yes, please read on!
About the Role
The Medical Editor/Writer is an integral member of the molecular diagnostics medical writing team that oversees delivery and execution of clinical study documents, such as validation plans, protocols, clinical study reports, and instruction for use and/or package inserts, as well as abstracts and scientific posters and manuscripts.
Medical writing tasks may include the research, development, authoring, and editing of technical and informational materials for various organizational needs and publications in one or more of the following areas: product labels, method sheets, package inserts, application sheets, customer bulletins and letters, or other electronic documentation or miscellaneous publications for both internal and external customer usage.
The primary focus of the Medical Editor/Writer will be on the high quality, error-free, properly formatted and timely delivery of each deliverable. The specific therapeutic areas of molecular diagnostics include, but are not limited to infectious diseases, blood screening, oncology and sequencing. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with multiple subject matter experts (SMEs), comments resolution, attention to detail, quality control, accountability, and strict adherence to SOPs and regulatory requirements.
The Medical Editor/Writer will be working closely with project-level SMEs (Medical and Scientific Affairs, Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and others), who will be primarily responsible for generating, changing, and/or updating scientific content.
- Scientific research and/or Medical Writing/Publication experience in life sciences industry
- Project management experience
- Experience working in Infectious Diseases area
- Med Tech certification desired
- Bachelor’s or Master’s degree in life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, clinical research, or other related/ relevant fields
- English as a primary language
Knowledge, Skills, and Abilities
- Knowledge and understanding of Good Publication Practices and clinical research process, including ICH GCP and FDA regulations
- Experience working with Templates, Style Guides, SharePoint, and Document Management Tools
- Reference management skills/ expertise with EndNote (preferred) or equivalent
- Meticulous attention to detail
- Strong interpersonal and communication skills
- Comfortable with virtual work environments and meetings
Kateric is a strategic partner for pharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution.
Kateric medical writers, editors, and quality control reviewers have extensive work experience and all possess an outstanding attention to detail. We have a working knowledge of drug development, a clear understanding of the application of governing regulations, and are highly adaptable to change.
Kateric’s resources are located across multiple time zones in the United States, as well as in India, the EU and Canada, and also have experience working with client teams located across the globe.