Job Description

We have a new Director/Snr Director of Medical Writing role we are supporting for an exciting Neurosciences company with a groundbreaking development platform and an exciting and growing pipeline.

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 Neurosciences and recognized Neuro Scientists. They are a now seeking a capable and highly experienced Director/Snr Director of Medical Writing to lead the growth and development of the new Medical Writing team, whilst operating as the lead medical writer for a number of potentially life changing indications in development.

This organization continues to steadily grow and expand in both people and indications, and this role will work closely with the leadership team including the CMO and VP of Clinical Development in a strategic role covering Clinical, Non-Clinical and Regulatory documents.

You will work cross-functionally to develop and finalize regulatory documents for submission, including IND modules, nonclinical study reports, investigator brochures (including initial IBs), clinical trials protocols, protocol amendments, informed consent forms, clinical study reports, scientific advice briefing documents, regulatory response documents, and safety updates.

The role will report into the VP of Regulatory Affairs who has over 20 years in Neuro and will be varied, strategic and offer many opportunities for an experienced 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 for projects that will range from Pre-IND through to NDA.

Duties:

• Prepare and manage clinical documents including investigator brochures, clinical study reports, briefing documents, clinical summaries for safety and efficacy, clinical overview, safety updates, responses to the authorities
• Independently plan, coordinate, develop, update, and revise key documents
• Provide medical writing subject matter expertise and leadership to project teams
• Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
• Collaborate effectively across functions within the organization as well as with external stakeholders
• Contribute to the development and standardization of templates and related processes to support the medical writing needs of a growing organization

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

If you are interested in hearing more about this role, please call me, Theo Moore on 587.216.9302 or let me know a good time for us to have a call where I can share more information, or alternatively send your profile to Theo@AdvTalent.com or my colleague Ivan Nash on Ivan.Nash@AdvTalent.com so we can respond and help to process your application.