Associate Director / Lead Medical Writer (fully remote) - A diverse role that will allow you to wear many hats!

Reference: JPC548

Expiry Date: 30-06-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Suffolk County
United States

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Job Description

We’re looking for a strong and energized medical writer to lead from the front in a diverse role that will allow you to wear many hats. The role will offer a mix of documents to work on (Regulatory, Clinical and Non-Clinical), and you will be the first permanent member of a developing Medical Writing team that is set to grow.

This role will suit you if you like to:

  • Do more than just write
  • Be involved in shaping the underlying strategies and narratives
  • Work closely with Regulatory Affairs
  • Positively influence and build strong working relationships
  • Develop new SOPs’ and processes
  • Come out of your lane to create new ideas and drive innovation
  • Initially work on early development projects (P1&P2) but enjoy the lead up and responsibility that goes with a major regulatory submission
  • Be a strategic thinker and leader who can look at the scope of a project and move things forward by organizing and liaising with the appropriate stakeholders
  • Be both Regulatory writer and Clinical writer
  • Set up and develop working relationships with new Vendors
  • Be instrumental in developing and expanding the Medical Writing department and in the longer term lead a growing team.

Our client is a clinical-stage drug research and development organization led by an impressive Executive Leadership team made up of mostly industry leaders in CNS/Psychiatry. They are seeking a highly motivated, well-organized, and skilled Associate Director of Medical Writing to lead cross-functional teams in content preparation for submission to regulatory authorities; partner closely with key stakeholders, apply critical thinking, be hands on in scientific writing and contribute strategically and scientifically at the project and/or program team level, when clinical and regulatory documentation is being evaluated.

The role will be varied and offer many opportunities for an experienced and well-versed Medical Writer to utilize all of their experiences and knowledge, not only in writing, but in setting up systems and processes and developing an integrated and resourceful medical writing team, with a strong voice for projects that will range from Phase 1 through to NDA.

Ideal candidates will have writing experience in clinical study reports, clinical study protocols, investigator's brochures, briefing documents, and other regulatory submission documents for INDs and NDA/BLA’s. You will need to have high-level content writing experience and experience with clinical development regulatory documents, with a strong working knowledge of statistical concepts and techniques. Excellent written and oral communication skills are needed and you will be an expert in the assimilation and interpretation of scientific content with adeptness in ability to translate for the appropriate audience.

In return you will have the flexibility to be fully remote and receive a top end package that includes a highly generous salary, bonus, stock and a number of personal and family benefits.

To Apply!

To apply for this role, please contact me, Ivan Nash on +1-908-378-8980 or send a full CV to and I will reply by return. Our team will support you throughout the interview and on-boarding experience.