We are a highly effective organization, and through collaboration and commitment we can execute on our mission. Our operating principles define how we work together to achieve our goals:
I am the Director of Sales Operations. My primary responsibility is ensuring that our field team has the information and tools they need to do their jobs successfully, always keeping in mind that our ultimate goal is to offer additional treatment options for healthcare providers and their patients. I am continuously looking to improve our systems and processes in ways that enable effective engagements with healthcare providers.
Our team has worked together to design and implement one of the most dynamic customer relationship management solutions I have seen, leveraging – and improving upon – the experiences our Sales, Market Access and Medical Affairs teams have had with previous systems. We have taken the time to think beyond what has been done before to create a unique system that supports both tactical and strategic efforts. By developing expertise internally, we are able to maintain a system that can be flexible as the treatment paradigm for opioid use disorder evolves.
Always remain open to change and the possibility that there may be a better way to do something.
I work in the Regulatory Affairs Department as a Regulatory Strategist with a focus on Nonclinical and Clinical Development. Regulatory Affairs professionals work closely with all departments to ensure that an asset is developed in a manner that meets the expectations of FDA, falls within the legal framework for drug development, and ensures access for patients who may benefit. We are always thinking of creative ways to ensure that we optimize access, and therefore benefit, to the patients while also meeting the regulatory expectations.
The regulatory team (and the company) had a huge win this year with regard to regulatory exclusivity. Being able to participate in the development of our strategy to support both the legal case for clinical exclusivity and the Citizen’s Petition for Orphan exclusivity was a very rewarding challenge.
Be an agile thinker. Indications falling within substance use disorder are complex and ever evolving. You must be able to think outside the box to support research and development activities in indications where there is not always a clear path to approval.