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Medical Writer I

053905_2

About the role

This vacancy has now expired. Please click here to view live vacancies.
 
"At ICON, it's our People that set us Apart"
 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com
 
 
Medical Writer I
 
Our key department values are:
 
Passionate about partnership
Quality without compromise
Flexibility in a dynamic environment
 
Role Responsibility
 
  • Preparation and QC of clinical and regulatory documents including protocols, clinical study reports, narratives and safety reports. This includes:
    • Working with internal study teams to determine/clarify project requirements and obtaining necessary information.
    • Tracking and recording progress against contracted hours/budget using financial tracking tools and the department’s project database. Early flagging to management of projects not on track and facilitation of the Change Order process.
    • Attendance at internal and external projects meetings via teleconference/Webex.
    • Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance.
    • Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments.
    • Perform QC of documents written by other writers.
  • To keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
  • Achievement of individual utilization (billability) target.
  • Compliance with department systems, e.g., project database, timesheets, training.
  • General operational assistance to the Medical Writing team.
  • Preparation and QC of other ad hoc document types, if required.
  • Active participation in department initiatives and process improvements.
  • Any other task deemed reasonable by department senior management.
 
Skills & experience required:
 
Essential:
  • Bachelor’s degree in a life science, or equivalent.
  • At least 1 year of experience as a clinical/regulatory Medical Writer or other technical/scientific writing role.
  • Able to assimilate and summarize large volumes of scientific data accurately, clearly and concisely.
  • Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook. Able to rapidly learn to use bespoke in-house and client toolbars.
  • Excellent verbal English.
  • Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting.
  • Excellent attention to detail.
Preferred:
  • Experience of working for a large CRO.
  • Familiarity with Veeva Vault, Salesforce and Box.
 
Competencies:
  • Able to recognize, exemplify and promote ICON's OwnIt culture and values of Accountability and Delivery, Integrity, Collaboration and Partnership.
  • Proactive, gracious and collaborative communication skills.
  • Able to work in a fast-paced, results-driven environment.
  • Culturally aware and able to work comfortably within a global team.
 
Other:
Expected travel 0%
 
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
#LI- SZ1  


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