Medical Writer I - Medical Imaging
About The Position
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. 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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- Ongoing development
- Opportunity to progress career
- Potential to move into other related areas to improve skillset
- Competitive benefits package
- International scope
- Continuous learning culture
- Challenging and engaging work
- Comprehensive and competitive total reward package
- Excellent level of base pay
- Wide range of variable pay and recognition programs
- Best in class employee benefits
- Supportive policies
- Wellbeing initiatives
- Various annual leave entitlements
- A range of health insurance offerings
- Competitive retirement planning offerings
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
