What are the responsibilities and job description for the Associate Director, Medical Writing - Neuroscience Job at Integrated Resources I position at Integrated Resources Inc.?
Associate Director, Medical Writing - Neuroscience
Full-time
Client is a Large Pharmaceutical Company
The 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 factors
Independently prepares and at times may direct, the writing of PCSs, protocols and protocol amendments
Independently prepares and at times may direct, all the writing of the CSRs including narratives
Works across functional areas to obtain all applicable source materials
Leads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports
Leads the medical writing activities for marketing application submission documents
Liaises with other functional areas and groups in the development of document standards and structure
Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design, and results across the program
Implements document quality controls, standards and best practices
Job Qualifications
BS required / MS preferred
Minimum of 8 years medical writing experience in an industry setting, with specific experience with compounds in Neuroscience
Must have participated in or lead a major marketing application submission
Strong critical thinking and problem solving skills
Self-motivated with the ability to influence others
Ability to multitask on complex projects
Result driven with a mastery of time management and project planning
Able to work on site
Advanced working knowledge of MS project and MS Word
Experienced in the use of a documentum system
All your information will be kept confidential according to EEO guidelines.
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