Description
Senior Medical WriterDescription
- Responsible for managing market application submissions and internal and external vendor support
- Develops medical writing project timelines
- 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.
- Facilitate implementation, adherence to and maintenance of guidelines, standards and templates through interactions with key stakeholders (eg, Shared Services).
- 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