junglevast.blogg.se - Medical writer salary research oncology at flatiron health

Medical writer salary research oncology at flatiron health how to#

Translate common review themes into best practices (e.g., templates) to optimize future collaborations.

Review documents generated by clients, providing review comments on draft and final documents as needed.

Interact with scientific publication team members to coordinate internal and external research reporting.

Consult with and collaborate with subject matter experts in clinical data, quantitative sciences, research clinicians, integrated quality management, regulatory affairs, regulatory policy, and other departments as needed to write various sections of documents.

Identify questions and issues during writing, proposing solutions and/or escalating as appropriate.

Be a key contact for research teams throughout the process of summarizing and reporting results.

Perform background literature research and write, review, edit, and coordinate content for clinical/regulatory documents.

Regulatory submission packages: Briefing Documents, Meeting Requests.

Protocols, protocol amendments, statistical analysis plans (SAP).

Develop or support a variety of document types such as:.

Act as clinical writing lead for relevant research projects across both the Prospective and Retrospective Business Units, managing and coordinating medical writing activities and information flow across different functions within study teams with minimal supervision.

Medical writer salary research oncology at flatiron health how to#

Assess relevant existing and proposed process flows across our Research teams and make recommendations to leadership about how to ensure scaling and efficiency of our regulatory writing capabilities and worksteams.

Maintain familiarity with evolving industry practices and regulatory requirements and guidelines that affect medical writing.Provide direction to our Research teams regarding writing/documentation best practices in accordance with AMWA, GCP, ICH-E3, and other industry standards development or modification of Standard Operating Procedures to meet life science and/or health authority standards is anticipated.In this role, you will be a leading individual contributor for our medical writing function across the organization, working with cross-functional teams to ensure Flatiron delivers high quality documents to our life sciences partners and other strategic collaborators as needed. Here's what you need to know about the role, our team and why Flatiron Health is the right next step in your career. We're looking for an experienced clinical regulatory medical writer, interested in innovation and looking to be a key member of research teams in a fast-paced, mission-driven environment. We have active partnerships with top-tier academic medical centers, the top 15 oncology biopharma companies, the FDA, and the NCI, all focused on using data to accelerate the research and treatment of cancer. Our technology-first approach has allowed us to build RWE data sets with higher quality, accuracy, recency, and scale than any other cancer data that are available. We believe that existing clinical research paradigms are ill-equipped to answer the research questions that face drug developers, academic researchers, and regulators in the oncology space today.įlatiron Research is focused on innovating in the real-world evidence (RWE) and clinical trials space. Our platform enables cancer researchers and care providers to learn from the experience of every patient. Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care.