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About Company

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us fulfill our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organization that delivers excellence to our clients and patients at every touchpoint. In short, to be the partner of choice in drug development.

Position Name :

Medical Writer I

Organization :

Icon Plc

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

2-3 years

Salary:

6.10 LPA

Location:

Work From Home

This is a rare opportunity to join our friendly global Medical Writing team within ICON’s Clinical Research Services group. Our remit is to produce high-quality documents supporting clinical studies and regulatory submissions.

Our key department values are:

  1. Passionate about partnership
  2. Quality without compromise
  3. Flexibility in a dynamic environment

Responsibilities:

  • Author and perform QC of Patient narratives.
  • Work with internal study teams to determine/clarify project requirements and obtain necessary information.
  • Track and record 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.
  • Attend internal and external project meetings via teleconference/Webex.
  • Write documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, adhering to regulatory or other guidance.
  • Incorporate review comments from internal and external reviewers, including management of multiple sets of comments.
  • Perform QC of documents written by other writers.
  • Keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
  • Achieve individual utilization (billability) target.
  • Comply with department systems, e.g., project database, timesheets, training.
  • Provide general operational assistance to the Medical Writing team.
  • Prepare and QC other document types, if required.
  • Actively participate in department initiatives and process improvements.
  • Perform any other task deemed reasonable by department senior management.

Skills & Experience Required

Essential:

  • Bachelor’s/master’s degree in pharmacy/life science, or equivalent.
  • At least 2-3 years of experience as a Narrative/clinical/regulatory Medical Writer.
  • Ability 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 and written English, with strong organization, syntax, grammar, clarity, focus, and messaging skills requiring minimal editing/rewriting.
  • Excellent attention to detail.

Preferred:

  • Good experience working on Oncology Narratives.
  • Experience working for a large CRO.
  • Familiarity with Veeva Vault, Salesforce, and Box.

Competencies:

  • Able to recognize, exemplify, and promote ICON’s Own It culture and values of Accountability & 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.

Application Link

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