Lead Clinical Content Strategist

15 uur geleden

Amsterdam, Noord-Holland, Nederland CSL Seqirus Voltijd
Job Summary

We are seeking a highly skilled Lead Clinical Content Strategist to join our team at CSL Seqirus. As a key member of our cross-functional clinical project teams, you will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D.

About the Role
  • You will be accountable for ensuring high-quality medical writing deliverables and disclosure/transparency activities, including study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, and regulatory dossiers.
  • You will develop medical writing and disclosure project timelines and collaborate with the Head of Medical Writing and Disclosure and the relevant Study Execution Team/Clinical Development Team.
  • You will coordinate and manage authoring teams and internal/external reviewers to facilitate document completion, content editing, formatting, quality checking, and publishing.

Key Responsibilities:

  • Develop and implement efficient processes for preparing high-quality medical writing deliverables and disclosure/transparency activities.
  • Collaborate with cross-functional teams to identify resource needs and develop strategies to meet those needs using internal resources and external vendors.
  • Maintain awareness of potential delays, problems, or gaps in information that exist in the team effort of document preparation to effectively manage the process.
  • Foster an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings, and use of international external networks.

Requirements:

  • An undergraduate degree in pharmacy, biological sciences, or related disciplines is essential.
  • Post-graduate qualifications desired (PhD or MD preferred).
  • Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry.
  • A minimum of 7 years Clinical experience in the role of medical writer.
  • Excellent level of English language proficiency.
Benefits

CSL Seqirus offers a competitive salary range of $120,000 - $160,000 per annum, depending on experience. Other benefits include professional development opportunities, a comprehensive employee benefits package, and a collaborative and dynamic work environment.

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