Role : Safety Writer
Company Name : Kateric
Company Website: katericonline.com
Experience : 4 - 6 Years
Mode of Interview: Virtual
Salary : As Per Industry Standared
Education : Masters or PhD in pharmacy or life sciences OR MBBS/BDS/BPT
Location: Remote
Hiring Process: Technical Interview, HR Interview
Job Description:
- 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
- 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
- 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
About Company :
A strategic partner for pharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution.
We believe that a successful strategic partnership is built on a strong foundation of governance, strategic thinking, collaboration, effective communication, and risk management.
Kateric’s core values— excellence, quality, accountability, and consistency —are the benchmark for everything we do and the framework from which we make all our decisions. Within this framework, Kateric strives to be a genuine partner who is able to consistently deliver on their commitments, while at the same time providing access to relevant services and capabilities over a range of product lifecycle needs.
Kateric uses a dedicated resource model, providing resources who work only for a single client, to ensure continuity of service and customer satisfaction. We develop the necessary infrastructure and tools for our resources to seamlessly integrate with the client teams and operate autonomously, while also providing them the necessary support, mentorship, and oversight to ensure achievement of established client goals.
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