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Strategic Solutions - Regulatory Affairs/ Drug Safety/ Quality Assurance

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 Submissions Support

Strategy

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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

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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

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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.

ICON has developed strategic partnerships with many of the world’s largest pharma companies - and every partnership evolves with our client's needs and Regulatory compliance. This is evidenced by our capabilities that have led to the approval of 18 of the world’s top 20 best-selling drugs. Regulatory Affairs is a growing group across the industry and we are proud to highlight many career opportunities globally.

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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.

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Hear from our Regulatory and Medical Writing team on their career growth at ICON Strategic Solutions.

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List #1

Roles in this area

Site Engagement Liaison

Salary

Location

Argentina

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Argentina

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

The Site Engagement Liaison (SEL) will develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in pharmaceutical industry clinical trials

Reference

2023-106246

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
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Site Engagement Liaison

Salary

Location

Buenos Aires

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Buenos Aires

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

The Site Engagement Liaison (SEL) will develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in pharmaceutical industry clinical trials

Reference

2023-106247

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
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Laboratory Supervisor, Bioanalytical Services

Salary

Location

Whitesboro, United States

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Whitesboro

United States

Business Area

ICON Strategic Solutions

Job Categories

Laboratory

Job Type

Permanent

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, biotech

Reference

2023-104079

Expiry date

01/01/0001

Kelly Purtle

Author

Kelly Purtle
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Clinical Quality and Training Manager South Africa & Sub-Saharan Africa

Salary

Location

South Africa

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

South Africa

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Quality Assurance

Job Type

Permanent

Description

As a Clinical Quality and Training Manager Sub-Saharan Africa region(South Africa Based), you will be joining the world’s largest & most comprehensive clinical research organisation, powered by health

Reference

2023-100750

Expiry date

01/01/0001

Shelly  Ball

Author

Shelly Ball
Shelly  Ball

Author

Shelly Ball
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Senior Regulatory Affairs Specialist (Post Marketing)

Salary

Location

Brazil

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Brazil

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

As a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2023-107055

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
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Clinical Labeling Coordinator

Salary

Location

North Wales

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

North Wales

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Logistics & Supplies

Job Type

Permanent

Description

As a Label and Translation Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Location: West Point, PA. Monday

Reference

2023-107044

Expiry date

01/01/0001

Brandon Pupek

Author

Brandon Pupek
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