Pharma Medical Writer Job at ICON, Apply Online Now
Medical Writer I – Imaging
CHENNAI
JR112117
MEDICAL WRITING ICON FULL SERVICE & CORPORATE SUPPORT OFFICE BASED
About the role
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 organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization 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:
- Passionate about partnership
- Quality without compromise
- Flexibility in a dynamic environment
The primary responsibilities and accountabilities of our Medical Writer – ICON Medical Imaging are:
- Prepare documentation for Blinded Independent Central Review (BICR) implementation for clinical trials
- Understand the imaging aspects of sponsor clinical protocols
- Understand image acquisition modalities
- Understand image assessment criteria
- Independently write and finalize Medical Imaging documents, including:
-
- Site Imaging Manual (SIM)
- Independent Review Charter (IRC)
- Independent Review Training Manual (IRTM)
- Liaise with internal groups, i.e., Medical and Scientific Affairs, Imaging Operations, and Clinical Operations to obtain necessary and relevant information and to deal with queries
- Independently interact with sponsors to obtain necessary information and deal with queries through effective decision making
- Inform the Manager-Medical Writing/designee of document status relative to quality and timelines
- Independently provide additional writing and editing services as required
What you need
- Advanced degree in a scientific discipline, preferably PhD, PharmD or MD
- 2+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting
- Knowledge of imaging guidelines for clinical trials, such as the FDA “Clinical Trial Imaging Endpoint Process Standards Guidance for Industry”
- Strong written and verbal interpersonal skills
- Good computer literacy
- Ability to work effectively and cooperatively with cross-functional teams
A desire to be a key part of a global network of services that lead to better outcomes for its clients, its people and for patients…apply now and Own IT@ICON!
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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