Expiry Date: 30-06-2023
Category Regulatory Affairs
Job Type: Full Time
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:
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 for this role, please contact me, Ivan Nash on +1-908-378-8980 or send a full CV to Ivan.Nash@AdvTalent.com and I will reply by return. Our team will support you throughout the interview and on-boarding experience.