Expiry Date: 31-08-2023
Category Regulatory Affairs
Job Type: Full Time
We are excited to be recruiting for a highly reputable client in Cell and Gene Therapy. Our client is a growing biotech with a solid pipeline in Rare Genetic Diseases who are now recruiting for a new Director or Associate Director of Medical Writing that is eager to utilize their team-management skills whilst continuing to develop and support key clinical and regulatory documents initially for products in early development and then for a number of key late-stage major submissions.
The position will allow you to work on an exciting portfolio of early dev products and see these projects all the way through to submission. You will also be able to shape the Medical Writing systems and processes and help to develop a team of medical writers who are engaged and passionate about their work.
As the Lead Medical Writer you will collaborate with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines. This position coordinates all activities required to produce medical writing deliverables, negotiates and manages timelines, and as required directs the work of other medical writers.
The role can be fully remote and comes with a generous basic salary, company stock and an exciting bonus plan.
What we really like about the company culture is that it is very engaging, friendly and collaborative. The teams are all led by executives with successful track records in regulatory strategy, submissions, and commercialization who all used to work in “ big pharma” and who all encourage strategic thinking and new creative ideas. The organization also has a number of lucrative and exciting long-term co-development and co-commercialization partnerships in place which has given our client a strong financial foundation, so they are stable and ready to build for the future. They have great data readout on their projects in development and both their R&D and manufacturing teams are steadily growing.
If you have solid background in clinical study protocols, IBs, briefing documents, and other regulatory submission documents for INDs and NDA/BLA’s and have experience in either building or leading a team of Medical Writers, we would be happy to support you with your application!
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 908.378.8980.