at ICON Strategic Solutions in Springfield, Illinois, United States
Job Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Senior Medical Writer
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
- Act as a lead medical writer on several projects from simple to complex level.
- Produce clinical documents as required.
- Provide scientific and medical writing consultancy to clients and internal colleagues at a moderate
level.
- Lead project teams in drafting report specifications, medical writing, and coordination of data analysis.
- May serve as an active mentor to one or more junior staff members.
- Schedule and conduct peer and team quality control review for assigned projects
- Write technical sections of regulatory documents, eg, protocols, clinical study reports, investigator
brochures, etc.
- Understand regulatory submissions requirements and clinical study report guidelines in host country.
- Exhibit excellent and oral communication and presentation skills.
- Demonstrate technical expertise and background in the use of medical writing templates and software
(eg, Please Review, document and submission content management platforms, etc.).
- Encounter problems that are varied but similar and require some factfinding to define problem.
- Select the best option from a set of defined procedures or based on precedence.
Education:
- Bachelor’s degree in science, health profession, or journalism required.
- At least 5 plus years of experience regulatory writing for pharma or biotechnology required.
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
- Experience managing writing activities for a major US or international regulatory submission (projecor people management) preferred.
Knowledge and Skills:
- Clear understanding of clinical development, including the phases, processes, and techniques usedwithin a clinical development environment from protocol design through regulatory submission andsupport for marketed products.
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Ability to understand Sponsor guidelines and requirements related to the preparation and productionof regulatory documents and submissions.
- Well-developed oral and written communication skills; ability to clearly present technical informationwithin and across functional areas.
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
- Knowledge of team dynamics and ability to function as a team leader.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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