Expiry Date: 31-07-2023
Category Regulatory Affairs
Job Type: Full Time
This is a clinical-stage drug R&D organization, a very reputable company with which we have worked for a long time. The company is led by a team of respected executives who’s track records in CNS and Psychiatry are extremely impressive. They are now looking for a skilled Associate Director of Medical Writing to lead the Medical Writing team and help it grow.
In this role you will also:
- Oversee and prepare content for submission to regulatory authorities; partner closely with key stakeholders, apply critical thinking, be hands on in scientific writing and contribute strategically and scientifically to the project
- Come out of your lane to develop new ideas and inspire innovation
- Work on early development projects (P1, P2) to see these programs all the way through submission
- Be instrumental in the writing of Regulatory, Clinical, and Non-Clinical documents
- Build and maintain lasting relationships with stakeholders and authorities.
This is a varied role which can offer a well-versed and pro-active Medical Writer with a strong voice the chance 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.
The company is very financially stable with great readout on the data for the products in their pipeline. They love the work they are doing and the difference they are making in the lives of their patients, which is why they are always eager to welcome passionate people on board.
To excel at this role you would:
- Have strong experience in clinical study reports, clinical study protocols, investigator's brochures, briefing documents, and other regulatory submission documents for INDs and NDA/BLA’s
- Have excellent written and oral communication skills, as well as the ability to interpret scientific content and translate for the appropriate audience.
The position is fully remote with a generous package that includes an impressive salary, solid bonus, stock and a number of personal and family benefits.
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.