Clinical Documentation Specialist

1 day ago


Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Group Full time
Job Overview:
Proclinical Staffing is seeking a highly skilled Senior Manager, Medical Writing to join our team. This role will be responsible for creating and maintaining clinical documents, ensuring compliance with regulations and standards. The ideal candidate will oversee contract writers and contribute to the planning and resourcing of writing deliverables.

Responsibilities:
  1. Produce high-quality writing deliverables on time.
  2. Plan, write, edit, and format key clinical documents independently.
  3. Manage the review and finalization process for documents.
  4. Represent Medical Writing on project teams and collaborate with the Director of Medical Writing.
  5. Work effectively with various internal and external stakeholders.
  6. Serve as a subject matter expert for clinical document production.
  7. Contribute to the development and maintenance of SOPs and templates.

Key Skills and Requirements:
  1. Bachelor's degree in Life Science or English/Communications with relevant expertise.
  2. Experience as a medical writer, preferably with regulatory submissions.
  3. Knowledge of Good Clinical Practices, FDA regulations, and the drug development process.
  4. Ability to manage multiple projects in a fast-paced environment.
  5. Strong attention to detail and timely completion of assignments.
  6. Proficiency in Microsoft Windows, Word, Excel, and PowerPoint.
  7. Ability to travel approximately 10%.
$62,000 - $90,000 per year.

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