Medical Writer I

5 months ago

Bengaluru Karnataka, India Icon plc Full time

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 to fulfil 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 organisation: Accountability &

Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients

and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the

friendliest people in the sector, and you’ll be helping shape an industry.

We have an incredible opportunity for an expert Medical Writer to join the team.
- The role:

- 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 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:

- Primary responsibility would be to author and perform QC of Patient narratives.
- 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 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/master’s degree in pharmacy/life science, or equivalent.
- At least 2-3 years of experience as a Narrative/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 mínimal editing/rewriting.
- Excellent attention to detail.
- Preferred:

- Good experience of working on Oncology Narratives.
- Experience of 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 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.
- Benefits of Working in ICON:

- Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
- We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
- We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
- But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
- ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qua

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