Agenda

• Overview of the traditional role of a medical writer and the ability to adapt
• Impact on clinical development and all aspects of a drugs life cycle
• Insights into team designing and training
• Value of a Medical Writing Group  on data and the ability to be vigilance

(Read Less)

• Impact of fair balance on scientific interpretation and communication
• "Scientific epistemology": how do we know what we know? A case-study approach to study design and levels of evidence
• "Cutting along the bias": when observational findings lead us astray

(Read Less)

• Overview of sharing data for all participants to understand
• Impact of plain language writing
• Data Sharing and privacy impact

(Read Less)

• How Jazz’s Medical Writing team provides strategic expertise and leadership to unlock organizational excellence
• Alignment between the Medical Writing & Transparency helps manage risk to the company through education and implementation of current and future Transparency regulations, including the public release of documents
• How Jazz’s Transparency function works cross-functionally to reach trial participants through Plain Language Summaries

(Read Less)

• Identifying what type of deadlines medical writers must adhere to, and navigating the deadlines based on the type of documents and regulatory requirements
• Timeline management
• Tips on how to promote interactions between cross-functional teams to enhance communications

(Read Less)

• Synergies between plain language and earlier functions
• Impact on transparency and disclosure practices
• Practical examples of plain language and health on communication strategies
• Facilitator towards improved patient engagement and centricity in clinical research

(Read Less)

• Role and Responsibilities of Medical Writing during pre- and post-submission
• Prepare for post-submission activities and FDA inspection
• Lessons learned: Do’s and Don’ts

(Read Less)

Medical writers in all areas of the field are often called on to work within a team of professionals and subject matter experts to complete their projects. Too often, the well-meaning contributions of those team members to our writing projects will combine to create challenging snarl of interpersonal, technological, and project management issues. In these situations, the medical writer’s expertise in preparing for and managing the process of collaborative editing is critical to the success of the project. This seminar will discuss the fundamentals of setting up and managing an effective collaborative editing process as well as key tools and resources for medical writers to assist them in developing and mastering this critical area of expertise.

(Read Less)

• Drive the project timelines to ensure all protocols are met and final projects are high quality
• Program and project management to ensure all deadlines are met
• Meet communication goals to assist take the scientific data turn into strategic papers, grants, education, communication 
• Overview of the medical writing career path and growth  
• Drive the storytelling in medical writing that impacts all aspects of the company

(Read Less)

• Operating decisively and planning for clinical regulatory medical writing teams
• Managing objectives and timelines
• Key insights for effective clinical overview 
• Lessons learned from remote work and virtual engagements

(Read Less)