Company Name: Icon Clinical Research India Private Limited
Designation: Medical Writer – All Levels
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
- 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.
- 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.
- 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