.As a Principal Medical Writer, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing: Acts as the medical writing expert for assigned drug projects, and leads the planning, development, and implementation of the content strategy of clinical submission documents (with input from appropriate expert functions).
Drives the design of clinical submission documents in support of the Clinical Development Plan, validates individual study protocol design, key messages of the clinical study report, and other clinical submission documents for assigned drug projects.
Leads the development of the project level data presentation strategy and messaging standards.
Independently authors submission documents and works with assigned Writers and other submission team experts in developing and implementing the submission authoring strategy for all clinical documents.
Works with Head Medical Writing Oncology to develop and implement authoring resource plans for all clinical submission documents of assigned drug projects.
Maintains current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects.
Responsible for the development of regulatory submission content strategy and leading cross-functional writing teams supporting high priority drug projects.
These projects will be on the critical path to drug submission and approval.
You are: 5-6 years experience in regulatory medical writing, 4 of which should be in writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.
), preferably in the area of oncology.
The incumbent must have experience in developing clinical documents in support of regulatory submissions globally (i.E., multiple regions).
This position requires a Master's degree in natural sciences; strong candidates with a Bachelor's degree will also be reviewed.
The incumbent must have a thorough understanding of the overall drug development process.
Specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions is required.
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs.
In addition, our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.
Our success depends on the knowledge, capabilities, and quality of our people.
That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development