Regulatory Affairs
At ICON Strategic Solutions, we are experts at helping our clients to navigate through the complexities of global regulatory requirements and emerging issues by supporting with resourcing provisions and ramp-ups of embedded Regulatory professionals.
Strategy
Having the right strategy is crucial at all stages of the product lifecycle. Whether you’re preparing for your first pre-IND/CTA meeting or approaching patent expiration, we will help you consider all the options so you can take the most strategic stance.
Submissions
Doing a submission right the first time can make the difference between being first to market or just another me-too. Whether it is an eCTD to the FDA, an orphan drug application in Europe, or a medical device, our experts will help you get to market quickly and smoothly.
Support
We provide temporary on-site support for organizations that find themselves suddenly overloaded. Our extra hands and minds can make things happen fast—and by providing you with regulatory assistance on routine work, our support can help you focus on your top priorities.
Pharmacovigilance & Drug Safety
ICON Strategic Solutions Pharmacovigilance team members bring together all safety services into a seamless and transparent delivery solution, with easy-to-review outputs, a strong focus on continuous quality improvement, and operational efficiency ensuring patient safety. Our client-embedded employees process cases based on an innovative cloud-based system, featuring automated and configurable business rules. This enables them to gain visibility into the safety profile of an investigational product throughout its lifecycle.
We provide a comprehensive range of drug safety services, minimising risk and protecting patient well-being from clinical development to post-marketing.
By using versatile technologies, targeted data collection, and reports from multiple sources, our experts support our clients in protecting patients. These services help to detect, assess, understand, quantify, and minimsze the risk of adverse reactions.
Pharmacovigilance is a growing area in the industry and we have many career opportunities available.
Quality Assurance
ICON Strategic Solutions has the resources to meet your requirements for Phase I - IV clinical trials.
In addition to providing in-house Quality Assurance auditing for all clinical trials, the Quality Assurance department provides stand-alone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GMP and GLP regulations.
Our QA services encompass the following:
- Auditing
- Phase I facilities
- Phase I - IV GCP audits
- Clinical laboratories (GCP, GLP)
- Database and Statistical tables
- Computer validation
- Clinical trial reports
- Pre-FDA/regulatory inspections
- Quality Systems Development (GCP, GLP)
With QA personnel located across Europe, the US, Asia-Pacific, Latin America and Japan, the ICON QA team is flexible enough to provide individual and personalised career development paths and services for locally managed projects.
Hear from our Regulatory and Medical Writing team on their career growth at ICON Strategic Solutions.
Salary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Job Categories
Quality Assurance
Job Type
Permanent
Description
As a Quality Control Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115196
Expiry date
01/01/0001
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Salary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Office Based
Job Categories
Other
Job Type
Permanent
Description
As a Optometrist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This position is located in Johns Creek, GA.
Reference
2024-115157
Expiry date
01/01/0001
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Salary
Location
Colombia
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Colombia
Remote Working
Remote
Job Categories
Drug Safety
Job Type
Permanent
Description
As a Senior Drug Safety Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmac
Reference
2024-114405
Expiry date
01/01/0001
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Salary
Location
India
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
India
Job Categories
Corporate Support
Job Type
Permanent
Description
Site Management AssociateLocation: Bangalore ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing
Reference
2024-113992
Expiry date
01/01/0001
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Salary
Location
India
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
India
Job Categories
Corporate Support
Job Type
Permanent
Description
This is an unique opportunity to join an exciting embedded sponsor team as Site Management Associate (SMA) in ICON Bangalore office. The SMA is accountable end to end from commit to study initiation u
Reference
2024-113991
Expiry date
01/01/0001
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Salary
Location
Korea, South
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
South Korea
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Regulatory Affairs Manager, Seoul, South Korea You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you i
Reference
2024-115136
Expiry date
01/01/0001
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