Regulatory Medical Content Specialist

2 weeks ago

Toronto, Ontario, Canada Thermo Fisher Scientific Full time

Be a Part of Accelerating Research and Solving Complex Scientific Challenges

About the Role

We are seeking a Senior Medical Writer to join our team at Thermo Fisher Scientific, a global leader in the life sciences industry. As a Senior Medical Writer, you will be responsible for providing high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.

Key Responsibilities

  • Serves as primary author for clinical study reports, study protocols, and summarizes data from clinical studies.
  • Researches, writes, or edits complex clinical and scientific documents, including IBs, INDs, and MAAs.
  • Reviews routine documents prepared by junior team members and provides training and mentorship on document preparation and regulatory requirements.
  • Ensures compliance with quality processes and requirements for assigned documents.
  • Represents the department at project launch meetings, review meetings, and project team meetings.

Requirements

  • Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 5+ years of regulatory writing).
  • Experience working in the pharmaceutical/CRO industry preferred.
  • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills.
  • Strong project management skills and excellent interpersonal skills, including problem-solving.
  • Excellent oral and written communication skills with strong presentation skills.

About Us

At Thermo Fisher Scientific, we enable our customers to make the world healthier, cleaner, and safer. We are a global organization with a local feel, and we value a work-life balance. Our Mission is to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. We are proud to be part of Thermo Fisher Scientific, a company that truly values its employees and provides opportunities for growth and development.

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