Kateric - Medical Writer/Editor - Remote/Contract
We are seeking medical writers and editors for remote-based contract opportunities (30-40 hours per week) with biopharmaceutical companies in clinical and non-clinical areas. To learn more about joining our global, cross-functional team, please read on!
About the Role
We currently have opportunities for medical writers and editors to work on clinical and nonclinical documents for pharmaceuticals, devices, and molecular diagnostics. Our writers and editors are responsible for the writing, editing, formatting, and/or managing of clinical and/or nonclinical regulatory documents (e.g., Briefing Packages, Investigator’s Brochures, CTD module documents, scientific manuscripts, validation plans/reports, state of the art documents, performance evaluation plan/reports, in vivo/in vitro reports [pharmacology, toxicology], etc.).
This is a remote, long term contract opportunity with an expected average commitment of 30-40 hours per week, with the potential for additional hours depending on project needs. Both U.S.- and E.U.-based candidates must be available to work during regular business hours in their respective time zones.
You will also:
- Represent medical writing as part of a global, cross-functional team and work independently to successfully drive the production and development of each deliverable following the client business process
- Ensure adherence to GCP, ICH guidelines, SOPs, and client templates and style guides.
- Interpret and present nonclinical, clinical, and scientific data
- Manage contributions from multiple, global cross-functional stakeholders
- Manage and communicate timelines to stakeholders
- Manage the review, adjudication, and finalization (approval, publishing) of each deliverable, as applicable
- Provide frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time
- Develop strong, lasting relationships with client teams that encourage organic new business growth
- BA/BS within a relevant scientific discipline, ELS certification preferred for editor positions, advanced degree preferred (MS or PhD)
- ELS certification preferred for editor positions
- 3+ years experience with medical writing/editing, preferably in the pharmaceutical industry
- Solid understanding of the drug/device development process, including the documents that are required at each stage and the roles of other functional areas and group interdependencies within research operations
- Knowledge and understanding of Good Publication Practices and clinical research process, including ICH GCP and FDA regulation
- Mastery of the English language and relevant scientific terminology
- Exceptional written and verbal communication skills
- Superior attention to detail
- Project management
- Experience working with Templates and Style Guides
- Skilled in the following technologies: Microsoft Suite (Word, PowerPoint, and Excel), Adobe Acrobat/PDF software, SharePoint, Document management systems and associated tools, EndNote or equivalent reference management software
Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution. 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.
How to Apply
Please click here to apply.