Medical Writer, Associate Director **Lead a team & support clinical and regulatory writing for an innovator in Rare Genetic Diseases **Full remote or MA

Reference: JPC563

Expiry Date: 31-07-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

If you’re an individual with strong medical writing experience, who enjoys providing strategic input, who is very collaborative with teams and stakeholders and likes to have an impact and think outside the box to drive innovation around processes and systems and SOPs - then this is a role for you!

About our client and the team:

Our client is a very well-funded pharmaceutical company offering a great opportunity to join them as a Lead Medical Writer, graded as an Associate Director in a role that also comes with team leadership. The executive team of the organization is made up of skilled industry leaders in their respective therapy areas and their innovative R&D platform, combines key technologies that are driving the development of multiple first-in-class, highly targeted therapies for a number of rare genetic diseases.

The company is small but growing, welcoming, and eager to connect with likeminded people. They like to keep the teams and groups feeling like a big family, encouraging open conversations. It’s a positive culture, where it is fun to interact with passionate professionals on all levels, and the focus is on trusting each other, relying on each other’s opinions, being involved and offering your suggestions and ideas.

The hiring manager for this position will also be the person you will be reporting to, she is the VP of Regulatory Affairs and has almost two decades worth of experience excelling at various roles in regulatory strategy, across a variety of therapy areas. Over the course of these years, she has made significant contributions to the development and filing of several meds and she is an encouraging leader who has advanced investigational drugs through all phases, negotiated NDA and sNDA approvals and led global regulatory strategy for marketed and development products.

Your responsibilities and experience:

  • You will be a pro-active and idea-driven person who can influence and develop relationships – you get what you need by building the bridges necessary to drive items to be competitive!
  • You will initially focus on early development (Phases 1 and 2) but with the idea you will follow these programs through to first/initial NDA
  • The day-to-day duties will involve both regulatory writing and clinical writing, with a solid amount of strategic input and the more you can and wish to lead - the more you will be encouraged to lead and take matters into your hands, and be a leading voice in your project teams
  • Documents may include 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.

Package and location:

  • The position comes with a competitive salary, stock, and bonus plan.
  • The role is also fully remote, so you can work from anywhere in the US.

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, or my colleague Ivan Nash on +1-908-378-8980.