Associate Director, Medical Writing

  • Temporary/Contract Positions
  • REMOTE

Associate Director, Medical Writing – Neuroscience & General Medicine

Term: anticipated 1 year – This is a contract to hire position

Fully Remote

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 team members/vendors on these programs.

  • As the lead writer, 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, 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.

Qualified candidates will have:

  • 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
  • Be able to work independently

Responsibilities:

  • 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

Qualifications

  • BS required/MS preferred
  • Minimum of 8 years industry 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
  • Advanced working knowledge of MS project and MS Word
  • Experienced in the use of a Documentum system

Company requires all contractors providing services to Company to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date