Principal Medical Writer (Regulatory) - Remote

Regulatory AffairsRemote, Canada


Description

Position at Premier Consulting

Join Premier Consulting, a division of Premier Research, and be a part of a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.  

We’re seeking a Principal Medical Writer (Regulatory) that is passionate about driving innovation from the earliest stages of development. As a member of the Premier Consulting team, you’ll build cross-functional partnerships that enable your growth and success. Help us create tangible solutions for patients in need. 

What you will be doing:

  • Independently write and format clinical and regulatory documents
  • Review and approve clinical and regulatory documents including: clinical study reports, in text tables, appendices, addendums, study plan outlines, synopses and protocols, and documents for regulatory submissions (e.g. meeting packages, Investigational New Drug (INDs) applications, and sections of marketing applications (NDA/BLA/MAA), Investigator Brochures, or other clinical and regulatory documents)
  • Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project
  • Review all source documents, perform literature searches, and interact with internal regulatory team members and external clients to develop a thorough understanding of project background, timelines, and goals
  • Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and guide more junior writers to assist in their preparation
  • Identify and solve problems relating to medical/regulatory writing issues

What we are searching for:

  • Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD/PharmD in a scientific or medical discipline preferred
  • BA/BS and 8+ years of experience in medical/technical writing; or MS and 6+ years of experience in medical/regulatory writing; or PhD/PharmD and 6+ years of experience in medical/regulatory writing
  • International experience desirable (EMA, TGA, PMDA)
  • Depth of industry and drug development knowledge
  • Strong knowledge and experience with Common Technical Document templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets

Why Choose Premier Consulting, a division of Premier Research?

  • 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 cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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. 

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