Posted to MedZilla on 3/26/2017


ProClinical

England, Medical Writer MC_LE_11172-MZ


 
 

ProClinical is seeking a Medical Writer on behalf of a leading medical devices company. The role is a full time, 12 contract that will include working from home 2 days a week, and will be based in Hatfield, UK.

Job Responsibilities:

  • This medical writer job will be working 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 the company in accordance with the ICH guidelines, international regulations, company standards and processes, and the company 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 medical 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 the company's 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.

Education and 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lisa Edgar on +44 203 7520 313 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.