Associate Director, Medical Writing - NeuroscienceThe Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Responsibilities include but are not limited to:Working on complex problems in which analysis of situations or data requires an in-depth evaluation of various factorsIndependently prepares and at times may direct, the writing of PCSs, protocols and protocol amendmentsIndependently prepares and at times may direct, all the writing of the CSRs including narrativesWorks across functional areas to obtain all applicable source materialsLeads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reportsLeads the medical writing activities for marketing application submission documentsLiaises with other functional areas and groups in the development of document standards and structureInteracts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design, and results across the programImplements document quality controls, standards and best practicesJob QualificationsBS required/MS preferredMinimum of 8 years medical writing experience in an industry setting, with specific experience with compounds in NeuroscienceMust have participated in or lead a major marketing application submissionStrong critical thinking and problem solving skillsSelf-motivated with the ability to influence othersAbility to multitask on complex projectsResult driven with a mastery of time management and project planningAble to work on siteAdvanced working knowledge of MS project and MS WordExperienced in the use of a documentum systemAll your information will be kept confidential according to EEO guidelines.