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Associate Director- Medical Writing

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Seeking a full time Associate Director of Medical Writing - Neuroscience & General Medicine. Major pharmaceutical client in Bergen County, NJ.

The Associate Director, Medical Writing will be the designated Lead Medical Writer for approximately two neuroscience programs, responsible for providing needed support and direction to other staff/contractors with regard to them. 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

- Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design, and results across the program

- 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

- Implements document quality controls, standards and best practices
- Bachelor's Degree required; an advanced degree is preferred.
- Minimum of 8 years medical writing experience, with specific experience with compounds in Neuroscience. Must have participated in or led 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
- Results 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

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