Head of COA Regulatory Strategy, Patient Centered Solutions

Reading, England, United Kingdom

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Candidates should possess a strong understanding of regulatory strategy, particularly within the pharmaceutical and medical device industries, with a focus on COA endpoints and Patient Experience Data (PED). Demonstrated experience in developing and implementing regulatory strategies for FDA, EMA, and other global regulatory agencies is essential, along with a deep knowledge of clinical trial design, data analysis, and regulatory guidelines. A relevant advanced degree, such as a Master's degree in Regulatory Affairs, Pharmaceutical Science, or a related field, is preferred.

Responsibilities

The Head of COA Regulatory Strategy will develop and deliver insightful regulatory strategies for clients, addressing complex issues related to COA endpoints and PED. They will support sales efforts by providing regulatory expertise, contribute to project delivery by providing regulatory insights and content, and serve as a subject matter expert and/or study lead on billable projects. Furthermore, this role involves building the regulatory capabilities of the PCS consulting organization through training, mentorship, and process improvement, maintaining an active external profile through engagement in industry groups and regulatory consultations, and leading the PCS thought leadership agenda for the regulatory capability.

Skills

Regulatory Strategy

Clinical Outcome Assessments (COAs)

Patient Experience Data (PED)

US FDA

EMA

Qualitative Research

Quantitative Research

Consulting

Life Sciences

Pharmaceuticals

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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