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Job Details

Senior Medical Writer (home based within UK)

Company: Covance
Location: Leeds, Maidenhead of remotely within UK
Reference: 64139BR
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

We are seeking a Senior Medical Writer to join our Global Medical Writing team in Leeds, UK. Remote work is an option.

Requirements:

At Covance, we are committed to advancing health care and bringing new medicines to market sooner. As the world’s most comprehensive contract research organization (CRO), we provide high-quality nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology companies to transforms today’s health care challenges into tomorrow’s solutions. 

 

We are seeking a Senior Medical Writer to join our Global Medical Writing team in Leeds, UK. Remote work is an option. 

 

  • The Global Medical Writing department is responsible for ensuring that work undertaken meets the requirements of government regulatory agencies locally and worldwide. This responsibility includes the preparation of a variety of clinical documents including clinical study reports for Phase II to IV clinical trials run by Covance globally, in collaboration with other Covance units as necessary. It is the responsibility of the Senior Medical Writer I to prepare such documentation to the required standard in a timely fashion. The Senior Medical Writer I is also responsible for providing this service and associated advice to clients. The Senior Medical Writer I is expected to acquire a competency in the use of the document management system and associated tools. 


Essential Job Duties: 

  • To carry out all activities in accordance with Covance Standard Operating Procedures and Good Clinical Practice (GCP) 
  • To record all project activities accurately on company standard timesheets 
  • To have a detailed knowledge of the Regulatory Guidances for ICH-E3 Clinical Study Reports and some familiarity with the Clinical (Efficacy or Safety) Sections of the Common Technical Document (CTD) 
  • Alternatively, the writer may have expertise in a specialized area of Medical Writing which is required for production of critical regulatory documents (e.g. patient narratives and pharmacovigilance documents). 
  • To have general knowledge and familiarity with electronic publishing and writing requirements 
  • To prepare documentation for regulatory submissions (e.g. investigator brochures, protocols, and clinical study reports) in collaboration with Clinical Research, Medical and Statistical personnel (as appropriate) to client and /or Covance specifications 
  • To work directly with client Medical/Statistical teams to plan and develop CSRs and with guidance from Senior Writing staff, higher level regulatory submissions (e.g., CTD Summaries) 
  • To be responsible for project coordination, as appropriate 
  • To provide advice on both local and global Medical Writing issues to project team members (internal and external to Covance) and help to resolve problems 
  • To prioritize and plan workload to a high standard; to advise Senior Management of significant problems promptly 
  • To provide advice and support for Business Development personnel regarding Time and Cost estimates, as requested 
  • To review and comment on reports generated within Covance or by client companies 
  • To participate independently in client meetings, as appropriate 
  • To build and maintain good Medical Writing relationships across functional units 
  • To regularly demonstrate initiative and ability to deal with complex and difficult situations independently 
  • To develop and implement ideas to improve the effectiveness and efficiency of the job 
  • To assist Senior Management to assess functional operations and plan for new procedures 
  • To assist in the development and training of Medical Writers and other Staff, as requested 
  • To undertake any activities involving communication with others, internally and externally, as requested 
  • To be available to other Operational Groups in times of low utilization for tasks commensurate with experience

 

Requirements:

  • Minimum of first degree in life sciences (or equivalent)•
  • Significant experience in the preparation of clinical documentation 
  • Experience in data handling and analysis 
  • Excellent written and verbal communication skills 
  • Ability to write fluent and grammatically correct English with an understanding of medical and scientific terminology and procedures 
  • Good word processing skills 
  • Good organizational and time management skills 
  • Attention to detail 
  • Ability to work to tight timelines while maintaining accuracy 
  • Ability to work to a variety of client-driven specifications 
  • Good team player 
  • Familiarity with quality assurance and quality control

 

Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.

 

Keywords:

Medica writer, economic writer, health economy, HE, GCP, ICH, regulatory writing.

Apply for this job: Senior Medical Writer (home based within UK)

Contact Information:

Address:  Covance Leeds
Leeds

England

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