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ABOUT THE ROLE

Job Responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
  • Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
  • Develops good working relationships with internal and external colleagues.
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develops or supports a variety of documents that include but not limited to:
    • Clinical study protocols and clinical protocol amendments;
    • Clinical study reports;
    • Patient narratives;
    • Clinical development plans;
    • IND submissions and annual reports; o Integrated summary reports;
    • NDA and (e)CTD submissions;
    • Investigator brochures, as well as;
    • Clinical journal manuscripts, clinical journal abstracts, and client presentations.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
  • Performs on-line clinical literature searches, as applicable.
  • Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
  • Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
  • Completes required administrated tasks within the specified time frames.
  • Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

 

What we’re looking for:

  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
  • Extensive knowledge of English grammar with a familiarity with AMA style guide.
  • Understanding of FDA and ICH regulations and guidelines strongly preferred.
  • Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team[1]oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet. 
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Sounds interesting?

Apply Now

SIMILAR ROLES

+44 203 475 84 31
68-70 S Lambeth Rd, Vauxhall London SW8 1RL