Senior Medical Writer

King of Prussia  ‐ Onsite
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Keywords

Description

Senior Medical Writer

Description
  • 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
Start date
07/2013
Duration
6-12 months
From
Real Staffing
Published at
21.09.2013
Project ID:
602498
Contract type
Freelance
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