Kateric Hiring for Safety Writer at Remote Full Time

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

About the Role

We currently have opportunities for Indian medical writers to author safety documents for pharmaceuticals. 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., Development Safety Update Reports, PSURs, PBRERs, RMPs 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. Pre-screen interview and proctored writing assessment are screening requirement 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

Masters or PhD in pharmacy or life sciences OR MBBS/BDS/BPT with relevant experience

4+ years of minimum experience with medical writing of safety 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

Why Join Kateric (benefits)?

We work with top global pharma companies providing enriching experience across a variety of clinical documents.

It is a full-time, remote working opportunity

We provide fixed annual salary patterns

We provide paid annual leaves

Flexibility to work in comfortable hours

Medical benefits

Regular yearly appraisals

…and many more!