Medical Typist Jobs in Canada

Senior/Principal Medical Writer

Job Details

Job Description

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 Senior/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.

The Senior or Principal Medical Writer works on problems of diverse scope and is responsible for authoring and managing the review and approval of moderate and complex clinical and regulatory documents including but not limited to clinical study reports, protocols, Investigator Brochures, non-clinical and clinical sections of the Common Technical Document, and other clinical documents. Converts scientific data into clear, scientifically sound, well-structured scientific, clinical, and regulatory documents intended for global health authorities and stakeholders, which follow relevant styles and provide references in support of a client’s product development plans and objectives. Understands study design and has an excellent working knowledge of Good Clinical Practices.

What you will be doing:

• Independently write and format clinical and regulatory documents
• Project manage assignments
• 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 regularly, and carry out contractual obligations for each assigned project
• Work on multiple projects and/or project teams at one time (dependent on the complexity and time commitment for each project) in collaboration with project managers and clients
• Interpret clinical and non-clinical data as needed to prepare documents
• Review all source documents, perform literature searches, and interact with internal regulatory team members and external clients to develop a thorough understanding of the project background, timelines, and goals
• Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents
• Aid in study design, GCP compliance, and effective responses to health authorities
• Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and guide more junior writers to assist in their preparation
• Edit and QC documents for other company medical writers and Regulatory Affairs team members
• Identify and solve problems relating to medical/regulatory writing issues
• Coordinate with other internal Regulatory Affairs and Regulatory Operations team members to develop deliverables for clients
• Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures, as well as help update and maintain templates
• Assist in the review of statistical analysis plans (SAPs) before database lock and provide feedback to the team when appropriate

What we are searching for:

• Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or Ph.D./PharmD in a scientific or medical discipline preferred
• BA/BS and 4-10 years of experience in medical/technical writing; or MS and 4 years of experience in medical/regulatory writing; or Ph.D./PharmD and 4+ years of experience in medical/regulatory writing
• International experience desirable (EMA, TGA, PMDA)
• Depth of industry and drug development knowledge
• Expert in literature search techniques
• 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
• Ability to learn fast, grasp the ‘essence’ of a strategy or a story quickly to convert relevant scientific data/information into high-quality summaries and reports
• Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously
• Well-developed analytical skills and strong knowledge of medical terminology
• Cross-therapeutic experience across therapeutic areas and phases