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Medical Writer – All Levels (Icon Clinical Research India Private Limited)

  • Medical Writer
  • Full time
  • 2 weeks ago
  • amod

Job Information

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    Salary Not Disclosed Not Disclosed / Monthly
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    Shift Round
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    No. of Openings 10 openings
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    Job Level : Senior
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    Job Experience : 2 - 5 Years
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    Job Qualifications bachelors or above

Job Description

Company Name: Icon Clinical Research India Private Limited

Designation: Medical Writer – All Levels

Location: Amod

Experience: 2 – 5 years

Qualification: UG :Any Graduate

PG :Any Postgraduate

Job Description: The role

  • This is a rare opportunity to join our friendly global Medical Writing team which sits within ICONs 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

In this role you will have the following responsibilities

  • Preparation and QC of imaging documents including Charters, Imaging Manuals and Training Manuals. 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 departments 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 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

  • Bachelors degree in a life science, or equivalent.
  • Previous 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 English.
  • Excellent 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 ICONs 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.

Salary: Not Disclosed

Website: https://careers.iconplc.com/job/medical-writer-all-levels-jobid-jr078057

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