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Scientific Documentation Expert

2 weeks ago

Dublin, Dublin City, Ireland Sigmar Recruitment Full time

Job Overview

We are seeking a Scientific Documentation Expert to join our team at Sigmar Recruitment. As a Medical Writer, you will be responsible for developing high-quality, scientifically accurate, and regulatory-compliant clinical trial documents that support the development of innovative therapies.

About the Role

The successful candidate will have extensive experience in medical writing within the clinical research/pharmaceutical industry, with a strong focus on Phase 1 and Phase 2 clinical trials. They will be responsible for authoring, reviewing, and finalizing clinical trial documents, including study protocols, initial investigator's brochures, clinical study reports, and manuscripts for publication in peer-reviewed journals.

Key Responsibilities

  • Develop comprehensive and scientifically rigorous protocols that align with regulatory and ethical standards.
  • Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.
  • Review and interpret clinical data to ensure accuracy and consistency in documentation, aligning with study objectives and regulatory expectations.
  • Collaborate with cross-functional teams to incorporate feedback and ensure alignment with study objectives and regulatory expectations.
  • Maintain organized records of all drafts, revisions, and approvals for future reference and audits.

Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
  • Strong experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.
  • Deep understanding of ICH GCP guidelines and compliance standards.
  • Proven track record of authoring and managing regulatory documents.
  • Exceptional writing skills and strong project management skills.
  • Technical proficiency in Microsoft Word, Excel, and other tools.