Associate Director, Medical Writing - Neuroscience

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 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 QualificationsBS required/MS preferred

Minimum 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 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 WordExperienced in the use of a documentum system

All your information will be kept confidential according to EEO guidelines.