Greater Philadelphia Area
2 months ago
My client is a global biopharmaceutical company with offices on both the East and West Coast. Their diverse portfolio consists of an expansive pipeline of innovative programs in the areas of neuroscience and hematology/oncology. They are well-established and widely recognized, offering stability and great growth prospects.
Currently seeking an Associate Director, Medical Writing to prepare high quality medical writing deliverables that support the company's clinical programs. You will be responsible for the messaging strategy across a program for the expanding portfolio at an internationally established company. Additionally, you will provide strategic input into development and submission plans to ensure all documents are executed with accuracy and consistency. Reports to Director, Medical Writing.
- Ensure that communication regarding clinical data is consistent through data presentation and messaging throughout the clinical development process
- Prepare medical writing deliverables according to budgets and timelines
- Evaluate submission plans to meet regulatory needs
- Work cross-functionally with members of Clinical Development, Biostatistics, and Drug Safety teams
- Review statements in deliverables to ensure they are accurate and supported by appropriate data
- Establish and maintain Best Practices and SOPs
- 6+ years writing experience in the pharmaceutical industry
- Regulatory experience including INDs and NDAs
- Demonstrated understanding of the clinical development process and the documents required in each phase
- Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
This is a very attractive opportunity to play a key role in the development of messaging strategy for the neuroscience and hematology/oncology portfolio of a world-renown biopharmaceutical company.
Please direct all questions to firstname.lastname@example.org or 347.305.7665.