Senior Regulatory Medical Writer - CRO

Location
London (Central), London (Greater) (GB)
Salary
Up to £65,000
Posted
22 Jul 2021
Closes
21 Aug 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

We're a global, world-leading clinical research organisation (CRO) that look to advance clinical research providing outsources services to pharmaceutical, biotechnology, medical device, and government and public health organisations. 

We are a team of experts, bright thinkers, dreamers changing the way the world experiences CROs, in the best way possible. 

Summary: The Senior Medical Writer is responsible for carrying out medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget, and to the written, scientific, and ethical standards in accordance with regulatory requirements.

Responsibilities:

  • Prepare study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other documents in accordance with regulatory requirements.
  • Prepare product documents such as investigator drug brochures, summary documents, and others in accordance with regulatory requirements.
  • Coordinate internal and client document review cycles.
  • Attend project-related meetings, as needed.
  • Perform review and QC of documents, as needed.
  • Serve as publishing point-of-contact in conjunction with the document coordinator to publish CSRs or other documents, as needed.
  • Create and manage project-specific timelines, an adaptation of timing, and milestones based on client needs/feedback.
  • Identify and appropriately communicate risks associated with document delivery and propose mitigation plans.
  • Advise project team and clients on medical writing-related issues.
  • Complete project-specific and company training, as assigned.

Qualifications:

  • Advanced degree in a relevant scientific/clinical/regulatory field preferred
  • At least 3 years of experience in a lead medical writing role in the pharmaceutical/CRO industry.
  • Excellent writing skills.
  • Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
  • Knowledge of current requirements and guidelines applicable to submission documents
  • Excellent interpersonal and oral communication skills.
  • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Ability to prioritize multiple projects

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