Medical Writer

Salary & Benefits
Competitive
Employment Type
Full Time, Contractor
Department
Medical Writing & Publishing, Oncology Business Group
Report to Position
Director, Medical Writing & Publishing
Location
EMEA Knowledge Centre, Hatfield, Hertfordshire
Business Area
EPCS
Application Deadline
30 June 2017

Full Job Description

Responsibilities:

  • The medical writer is expected to work directly with clinical study teams, the oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
  • Should be able to prepare regulatory documents on behalf of Eisai in accordance with the ICH guidelines, international regulations, Eisai standards and processes, and the Eisai Writing Style Guide as applicable.
  • Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator Brochures, and submission documents. Responsible for managing the document review process.  Route documents for approval. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.
  • As a representative of the core oncology medical writing group, act as a liaison between the UK teams and the MW group in US.
  • Participate in project team meetings to provide input regarding deliverables, timelines, and processes, consistent with the Eisai global practices as adopted by the oncology medical writing group.
  • Inform the director about the medical writing needs in UK.
  • Help to ensure procurement of adequate and quality resources to complete EU-specific medical writing deliverables.
  • At the director’s discretion, offer guidance to these external vendors.

 

Qualifications:

  • Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred or equivalent.

 

Experience:

  • Demonstrated experience of writing regulatory documents in the pharmaceutical industry.
  • Prior experience in oncology is a plus.
  • The ability to independently write regulatory documents in collaboration with the various members of study team.
  • Excellent writing skills, meticulous attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data. The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.