Premier Consulting, a division of Premier Research, is seeking a Principal Medical Writer
. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process. What you’ll be doing:
What we’re searching for:
- Lead a group of writers assigned to a project, manage the greater project, and assign tasks to project team writers
- Act as lead writer; contributes to clinical and regulatory document creation, review the work of projects writers
- Act as principal liaison to project stakeholders
- Work with regulatory strategist(s) and other stakeholders to create submission strategies, timelines, for regulatory submissions (e.g. meeting packages, Investigational New Drug [INDs] applications, and sections of marketing applications [NDA/BLA/MAA])
- Creates clinical and regulatory documents according to ICH guidance
- Ensure timeline adherence of project writers and self, provide project status updates on a regular basis to stakeholders, leads and managers
Why choose Premier Research?
- Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
- 10+ years of medical writing experience in a pharmaceutical company or a contract research organization
- Maintains current knowledge of ICH and local regulatory authority drug research and development regulations
- Experience mentoring and training staff
- Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and relevant regulatory‑writing style
• Premier Research is more than a company - it’s a community of people that truly
care about one another, about our clients, and about our mission of furthering
research to improve the lives of patients in critical need.
• Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our
staff with innovative technologies and continuous learning opportunities so that they
have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse
population, we require the perspectives of a diverse staff thinking creatively, challenging ideas,
and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion,
and empowerment, we create a community of belonging that welcomes differences, fuels
innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal
guidelines. All qualified applicants will receive equitable consideration without regard to race,
color, religion, sexual orientation, gender identity, national origin, disability or veteran status.