Kateric - Medical Writer - Remote
As we are expanding our team, Kateric is thrilled to announce that we are looking for experienced regulatory writers located in India to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical regulatory documents. This is a full-time, remote, salaried opportunity .
Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution. Kateric’s team members are located across India as well as the United States (across all time zones), 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 India to author a wide variety of clinical 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 range of document types (e.g., Protocols, Briefing Packages, Investigator’s Brochures, Clinical Study Reports, 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.
Flexibility to work some evening hours to accommodate global client meetings is needed. A pre-screening interview and proctored writing assessment are screening requirements as part of the recruiting process.
Here are some of the wonderful benefits you will enjoy while working with Kateric:
- Broad range of clinical documents and therapy areas
- Fully remote
- Annualized, fixed salary
- Technology bonus (for laptop purchase)
- Signing bonus (dependent upon experience)
- Paid annual leave/statutory holidays
- Flexible working hours
- 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
- Advanced degree (PharmD, PhD, MBBS/BDS/BPT, Masters) within a relevant scientific discipline
- 3+ years of minimum experience with medical writing of clinical regulatory documents, preferably in the pharmaceutical industry
- Solid understanding of the drug development process, clinical trial phases, 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
- Exposure of working on variety of therapeutic areas helpful
- 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
- Document management systems and associated tools
- Work experience on Veeva Vault is a plus
Compensation will be based on Indian industry standards and candidate’s experience and qualifications.
Good luck with your application! To Apply, please click here.