Description:
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/vendors 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 (eg, NDA, MAA)
- 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 inducstry experience with 5 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
Job Requirements
- Position is temp to perm
- Exposure to and primary author of:
o Regulatory marketing application NDA & MAA
o Clinical study reports
- 8 years in pharma with a minimum of 5 years in medical writing
- Neurology experience required
- 1 day/week work from home
- Be able to work independently