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13 Feb 2013
Full-Time Manager, Technical Writing (Seattle, WA)
|Job Title:||Manager, Technical Writing|
|Area of Interest:||Medical Affairs|
|Job Description:||Dendreon is seeking a Manager to support the Technical Writing Center of Excellence. The Manager will provide leadership to the Technical Writing Center of Excellence, assist with resource planning, ensure high-quality output, and drive timelines. This role is key to the execution of the publication plan as well as delivery of clinical and regulatory documents.
Primary Duties and Responsibilities
• Manage writing team within the Technical Writing Center of Excellence. Develop and evaluate personnel to ensure the efficient functional operation. Assist with managing/planning resource for the team’s deliverables, including but not limited to: external publications (abstracts, posters, slide decks, manuscripts), investigator brochures, study protocols, interim and final clinical study reports, annual reports, and integrated summaries of safety and efficacy.
• Oversee quality of deliverables that meet Dendreon standards for style and format and adhere to FDA/EMA or other appropriate regulatory guidelines. Provide team support through document editing, QC, and formatting.
• Ensure delivery of all documents in accordance with predefined timelines. Provide input for planning efficient work plans and timelines. Effectively track projects and provide regular status updates to internal team. Proactively support teams to resolve issues and escalate problems, as necessary. Manage coordination of required internal team reviews and sign-offs.
• Ensure team adherence to standard practices and SOPs; eg, filing standards, document review and approval. Provide recommendations for establishing new and improving existing practices/guidelines.
• Maintain and manage effective use of document review system.
• Serve as lead writer on assigned cross-functional project teams. Prepare scientific publications (abstracts, posters, slide decks, manuscripts) and/or clinical/regulatory documents. Liaise/coordinate with medical directors and/or medical monitors and external investigators/authors to create and manage the review of documents, and follow-up with other functional groups for materials needed for document completion.
• Assist the Head, Publication Planning and Technical Writing Center of Excellence in overseeing projects assigned to vendors (eg, timeline development and management).
|Requirements:||• Bachelor’s degree in a scientific discipline or equivalent; advanced degree (PhD, PharmD, MD) preferred
• A minimum of 5 years of industry writing experience.
• Prior management experience; experience managing writing group preferred.
• Basic knowledge of the clinical research process and FDA and ICH guidelines regulations/guidelines
• Strong organizational, interpersonal and verbal and written communication skills
• A flexible attitude with respect to work assignments and new learning
• Strong team leadership skills with an ability to facilitate meetings with matrix teams
• Excellent time management skills with an ability to manage multiple, varied tasks and prioritize workload
• Proficient in MS Office applications
|Working Conditions & Physical Requirements:||The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.|