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Medical Writer/Senior Medical Writer - Imaging

India-Bangalore; India-Chennai
Permanent
Reference: 057181_2
This vacancy has now expired.
Description
This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON’s Clinical Research Services group. Our remit is to produce high quality documents supporting Phase I-III clinical studies and regulatory submissions.
 
Our key department values are:
 
  1. Passionate about partnership
  2. Quality without compromise
  3. Flexibility in a dynamic environment
 
We have an opening for a Medical Writer
 
In this role you will have the following responsibilities:
  •  Preparation and QC of imaging documents including Charters, Imaging Manuals and Training Manuals. This includes:

o   Working with internal study teams to determine/clarify project requirements and obtaining necessary information.

o   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.

o   Attendance at internal and external projects meetings via teleconference/Webex.

o   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.

o   Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments.

o   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 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.
  •          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 and written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting.
  •         Excellent attention to detail.

Preferred:

  •          Knowledge of imaging techniques such as CT, MRI, PET, Echo, X-ray, DxCT.
  •          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.

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