Kateric - Regulatory Medical Writers - Remote/Contract
About the Role
We currently have opportunities for medical writers to work with pharmaceutical companies in both clinical and nonclinical areas with a broad description as follows.
This is a remote, 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.
In this role, you will be responsible for writing, editing, formatting, and/or managing clinical and/or nonclinical regulatory documents. Examples of clinical documents include but are not limited to: Briefing Packages, Investigator Brochures, Clinical Study Reports, IND applications, Protocols, and CTD Clinical summary documents.
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 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
About You:
- BA/BS within a relevant scientific discipline, ELS certification preferred for editor positions, advanced degree preferred (MS or PhD)
- 3-5 years scientific research and/or medical writing/publication experience in the life sciences industry
- Solid understanding of the clinical development process, including the documents that are required at each stage and the roles of other functional areas and group interdependencies within research operations
- Exceptional written and verbal communication skills, both with internal and external teams
- Mastery of the English language and relevant scientific terminology
- Knowledge and understanding of Good Publication Practices and clinical research process, including ICH GCP and FDA regulation
- Experience working with Templates, Style Guides, SharePoint, and Document Management Systems
- Computer skills/expertise in Microsoft Word/ Powerpoint/ Excel and Adobe Acrobat/ PDF software with a specific focus on word processing, tables, document formatting, and styles
- Strong competency in using document management systems and associated tools
- Reference management skills/ expertise with EndNote (preferred) or equivalent
- Strong attention to detail and project management skills
About Us
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.
How to Apply
Please forward a CV to lucy@amycelltalent.com