Contract Senior Medical Writer

OncoBay Clinical is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we’ve built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. As we continue to grow, we are looking for a highly-motivated contract senior medical writer to help us deliver new, life-changing therapies for the patients with cancer who need them.

Are you ready to think outside the box and drive results?

As a Senior Medical Writer, you will:

  • Contribute to key clinical and regulatory document content and critically assess, interpret, and summarize data.
  • Support in the development of standards, style guides, templates, procedures (e.g., SOPs) and optimized processes for clinical and regulatory document development.
  • Support the writing and preparation of clinical study summaries and other scientific and regulatory communications, as needed, for clinical research projects.
  • Assist in the conduct of literature reviews in support of Protocol development and regulatory submissions.
  • Perform QC checks on the data in reports to ensure the timely preparation and submission of critical clinical and regulatory documents

Knowledge, skills and abilities:

  • Knowledge of GCP, ICH, GDPR or other applicable regulations.
  • Knowledge and application of medical communication standards and best practices.
  • Advanced knowledge of researching, writing, editing, and reviewing clinical documents.
  • Advanced understanding of clinical data analysis, reporting, and presentation.
  • Ability to integrate, interpret, and summarize scientific data from a variety of primary sources in a clear and concise manner.
  • Expert in AMA style.
  • Excellent understanding of syntax and English grammar.
  • Expert in MS Word.

Requirements:

  • Bachelor’s degree or equivalent in life sciences, or equivalent experience; advanced degree preferred.
  • At least 5 years of experience in clinical research, including at least 3 years of CRO experience.

Location: Germany, Poland, Spain - This position is fully remote

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