Medical Writer - Kateric - Remote Role

Are you an experienced medical writer who is a team player and wants to work in the biopharmaceutical industry? If yes, read more!

We are looking for experienced regulatory writers in North America and Europe to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a remote, long-term opportunity with an expected average commitment of 30-40 hours per week, with the potential for additional hours depending on project needs.

About Us

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, Europe, and Canada, and also have experience working with client teams located across the globe.

About the Role

We currently have opportunities for experienced regulatory medical writers in either North America or Europe to author clinical and safety documents for pharmaceutical products across multiple therapy areas including oncology. Our writers are responsible for driving the development of each deliverable including de novo writing (to varying levels) and/or managing stakeholder contributions, ensuring adherence to client styles and formatting, managing stakeholder expectations, and ensuring timeline integrity across a wide variety of document types (e.g., Protocols, Briefing Packages, Investigator’s Brochures, Clinical Study Reports, DSURs, PBRERs, CTD module documents, etc.).

We provide the training, tools, infrastructure, and support needed for our writers to be successful. We also provide significant development opportunities for our team members resulting in exposure to a wide variety of document/product types and therapy areas.

Candidates must be available to work during regular business hours in their respective time zones (US or Europe), with flexibility to accommodate global client meetings as needed. A pre-screening interview and proctored writing assessment are screening requirements as part of the recruiting process.

Additional Responsibilities

• 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

Background

• Advanced degree (PharmD, PhD, Masters) within a relevant scientific discipline; BS degree may be considered with at least 10 years of relevant medical writing experience
• 3+ years of minimum experience with medical writing of clinical and/or safety regulatory documents, preferably in the pharmaceutical industry

Knowledge

• Solid understanding of the drug 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

Skills

• Exceptional written and verbal communication skills
• Superior attention to detail
• Project/stakeholder management
• Experience working with templates and style guides
• Skilled (mastery level) in the following technologies:
  • Microsoft Suite (Word, PowerPoint, and Excel)
  • Adobe Acrobat/PDF software
  • SharePoint
  • Document management systems and associated tools

Compensation

• Compensation will be based on a candidate’s experience and qualifications.