Description
Senior Medical WriterThe Senior Medical Writer will be responsible for independently writing and reviewing CSR's, IB's, and Protocols. Additionally, the Senior Medical Writer will perform lead duties on MAA, BLA, NDA and other regulatory submission within various therapeutic areas of a Global Pharmaceutical Company. The Senior Medical Writer will also assist in vendor management.
Description
- Responsible for managing market application submissions and internal and external vendor support
- Coordinates and manages the tasks, roles, responsibilities and timing of the authoring team and internal / external reviewers to facilitate document completion
- Responsible for ensuring the appropriate plan, process and tools are in place for content editing, formatting, quality checking and publishing.
- Facilitates document finalisation, approval and electronic publishing.
- Proactively determine the needed changes to existing or creation of new guideline, standards and templates.
- Ensure in-house / external resource available to provide medical writing deliverables as required by project team and in line with company objectives.
- Provides input into the strategy for medical writing vendor selection, defines the scope of work to be outsourced and is responsible for medical writing vendor management.
- Develop and maintain specific medical writing vendor relationships where required.
- Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
Qualifications
Education
* An undergraduate degree in pharmacy, biological sciences or related disciplines is essential
* Post-graduate qualifications desired (PhD or MD preferred)
Experience
* Experience driving/managing market application dossier submissions (eg, NDA, MAA, BLA, etc)
* prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
* As a guide, a minimum of 4 years Clinical experience in the role of medical writer
* A solid understanding of the Clinical Development Process
* Ability to write clearly and logically .
* An excellent understanding of all aspects of ICH GCP, SOPs, and international publication planning guidelines
To find out more about Real please visit www.realstaffing.com