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WHAT
IN
Director Medical Writing - Janssen AI LLC
Job
Johnson & Johnson
US
-
South San Francisco,
California
Job Code - 14935
Position - See job description
Job First Active on: Wednesday, November 04, 2009
APPLY TO THIS JOB (You will be applying directly to Johnson & Johnson for this position!)
JOB DESCRIPTION: Director, Medical Writing - Janssen AI, LLC
The Director, Medical Writing, Janssen Alzheimer Immunotherapy Research & Development, LLC, leads and is accountable for all medical writing activities for Janssen AI, and supervises all medical writers and other medical writing resources, including medical writer contractors. Responsibilities include resource planning; interviewing, hiring, and training employees; establishing priorities; providing oversight with regard to quality standards; setting objectives; appraising performance; fostering career development; rewarding and disciplining employees; addressing complaints and resolving conflicts. Responsibilities, either personally or via medical writer subordinates within Janssen AI include: As a member of a clinical team, researching, writing, and managing the production of clinical documents and materials, including but not limited to: Investigator brochures, clinical study reports, clinical summaries, clinical overviews, protocols, protocol amendments, annual safety updates, abstracts, posters, publications, presentations, and materials for sales and marketing. Reviewing analyses and data presentations to be used in study reports or other documents. Providing input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines. Ensuring that all clinical documents are produced according to appropriate Janssen AI SOPs and business practices. Potentially supervising contract medical writers for clinical documents. Developing, implementing and using templates and guidelines for clinical documentation. Potentially providing template training to teams. Supporting clinical teams in protocol and CRF development. Reviewing pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.
REQUIREMENTS - QUALIFICATIONS: Director, Medical Writing - Janssen AI, LLC
A minimum of a Bachelor's degree in a science or communication discipline with a minimum of 10 years medical writing experience in the clinical or laboratory setting, OR an Advanced Degree with 7 years medical writing experience in a clinical or laboratory setting preferred. Excellent leadership and management experience. Good understanding of experimental methods, research design, and statistical analysis. Ability to analyze medical data and interpret its significance within a pharmaceutical setting. Ability to interpret, analyze, and present statistical data obtained in a clinical trial. Advanced scientific, technical reading, writing and editing skills. Excellent oral communication skills. Proficient computer and word processing skills. Use of templates and experience with document management systems. Up to 5% yearly travel may be required (International as well as Domestic).
Johnson & Johnson
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