Director Medical Writing - CA (or TX, CT)

This established, growing pharmaceutical has an immediate opening for a Director of Medical Writing.  Excellent salary, benefits, relocation assistance offered.  Can base in CA, TX, CT.

 

Responsibilities:Plan & direct all documentation and communications concerning global clinical research projects:

• Directs the global medical writing staff in the coordination and management of contract medical writers and CROs for the production of Clinical Study Reports, Investigator Brochures and other written material used in clinical research.
• Collaborates with Clinical Team Leaders and Document Management staff to ensure delivery of high quality documents with agreed timelines
• Consults with the product and project teams to plan and manage writing and communication resources for CDPs, Investigator Brochures, Protocols, Amendments and Study reports
• Plans and manages resources in the US and EU offices to ensure production and publication of complete study reports (including all appendices); Negotiates and makes agreements for medical writing contract support. Develops and manages external contractors and provides expert medical writing support for individual clinical studies and projects.
• Establishes systems to track, coordinate and manage workload across projects
• Coordination with Regulatory Affairs regarding format and content of clinical documents for regulatory submissions in the US, EU and other countries.
• Provides strategic direction and coordination with other departments to evaluate, procure and implement writing and communication tools.
• Participates in the development of SOPs regarding Clinical Study Reports, Protocols, Investigator’s Brochures and manuscripts for publication
Requirements:

• Master’s degree and/or PHD in the medical or life sciences is preferred.
• 8+ years of Medical Writing experience
• 4 years managing medical writing staff/resources

• Experience with document management systems
• Experience with implementation of document standards and templates

 

Please send resume in  a word format attachment to execquest@comcast.net or phone Lisa FitzGerald for more information.