Expiry Date: 31-07-2023
Category Regulatory Affairs
Job Type: Full Time
Our client is a clinical-stage drug research and development organization led by an impressive Executive Leadership team. They are well funded, and their pipeline indications are based on their innovative and groundbreaking new approach to treating a number of rare genetic diseases across several therapeutic areas.
Due to expansion and growth of their pipeline they are now searching for a highly experienced Medical Writer at Associate Director grade to operate as a strategic medical writer for a number of potentially life changing indications in a varied role that will cover all aspects of medical writing for Non-clinical, Clinical and Regulatory documents. The role will cover and involve documents from Pre-IND to supporting a new NDA/BLA and agency interactions/responses. You will also support the growth and development of the Medical Writing function by providing input around new systems and processes and by managing people (consultants and CRO’s).
The Ideal candidate will have writing experience in clinical study reports, clinical study protocols, investigator's brochures, briefing documents, and other regulatory submission documents for INDs and in the future, NDAs. You will also 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 and the ability to translate for the appropriate audience.
In return you will have the flexibility to be fully remote, in a role where you will be fully supported in having a great work-life balance and receiving a generous package that includes a good salary, bonus, and LTIs/stock options/RSU’s.
If you are interested in hearing more about this or other roles in Medical Writing, please contact me, Theo Moore on 587.216.9302 or via email Theo@Advtalent.com, or my colleague Ivan Nash on +1-908-378-8980.