Medical Writer

2 weeks ago

Old Toronto, Canada Grifols, S.A Full time
About the Role

We are seeking a highly skilled Medical Writer to join our team at Grifols, S.A. in the United States. As a key member of our clinical research and regulatory medical writing team, you will play a critical role in the development and publication of clinical study reports, abstracts, and other scientific documents.

The successful candidate will have excellent scientific, technical, and clinical studies knowledge, with the ability to interpret and analyze complex data. You will work closely with various teams, including internal and external stakeholders, to engage all parties who contribute to writing sections of documents, review, and approve final documents according to planned timelines.

Responsibilities
  • Author first and subsequent drafts of clinical study reports from data generated from clinical studies, utilizing ability to understand and interpret the data from tables and graphs and placing them in written and diagrammatic format with the medical/scientific perspective.
  • Utilize statistical and medical literature evaluation skills to compare data and potential citations for generation of these documents, using appropriate style, grammar, and flow and assuming responsibility for completeness, accuracy, and content of the prepared document.
  • Organize material with co-authors, format, and coordinate processes for internal review and prepare the clinical report for final sign off, ensuring that the production of final report is according to departmental SOPs.
  • Author first (and subsequent) drafts of documents or abstracts/posters from data from clinical studies or other sources such as drug safety, or from published sources.
  • Provide authorship support to Medical Directors for protocol shells, updating the investigator brochures, annual safety reports, and for regulatory documents such as sections of Biological License Applications to FDA and other regulatory agencies.
  • Interface and assist physicians, key opinion leaders that may be involved in preparing documents to provide editorial assistance.
  • Assist publications planning team in integrating the science of Grifols products and relevant clinical study results into the strategic planning and execution of product publication.
  • Ensure implementation of quality control (QC) and other critical quality aspects for final documents, driving document production timelines according to established plans.
  • Maintain Clinical Study Registry and Results Disclosure, within current worldwide regulations, interfacing and uploading clinical protocol registration data and clinical study report disclosure data to FDA CT.gov, EU, and other worldwide website registries.
Requirements
  • Bachelor's degree in science or related field with coursework in biology, pharmacy, or related areas. Advanced degree (MS, PhD, or PharmD) preferred.
  • Typically requires 8 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD in statistics, equivalency is 5 years of pharmaceutical experience.)
Benefits

As a Medical Writer at Grifols, S.A., you can expect a competitive salary of $120,000 per year, based on industry standards and location. In addition to a comprehensive benefits package, you will also have opportunities for professional growth and development, working with a talented team of professionals in the pharmaceutical industry.

Why Join Us?

Grifols, S.A. is a global healthcare company dedicated to improving human health and well-being. We offer a dynamic work environment, opportunities for career advancement, and a commitment to excellence in everything we do. If you are passionate about medical writing and want to make a difference in the lives of millions of people, join our team today

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