Clinical Regulatory Intelligence Analyst

Analyst

OVERVIEW OF ROLE – CLINICAL PROFILE

Based in our India office (Bangalore / Gurgaon), we seek a skilled Individual contributor proficient in applying subject matter expertise. The successful candidate will be responsible for the creation and upkeep of high-quality regulatory intelligence content focusing on Clinical Trial Data. Responsibilities also include managing day-to-day operations for IQVIA Regulatory Intelligence, covering planning, client delivery, and maintaining quality standards.

RESPONSIBILITIES

• Prepares, reviews, and updates regulatory documentation in the area of clinical trials based on documents published by regulatory authorities as appropriate with particular focus on APAC region and EU region.
• Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, completeness, and accuracy) regulatory intelligence related to clinical trials, as per defined quality processes.
• Performs quality control activities of external expert contributions within the area of clinical trials.
• Provides knowledge related to clinical trials to support inquiries from customers, sales, marketing, and business development.
• Acts as a subject matter expert of Regulatory knowledge in clinical trials as applicable.
• Translate regulatory documents using professional software tools and conduct quality checks by proofreading/reviewing machine translations to ensure adherence to customer’s’ and company’s quality standards.
• Control and improve machine-translation quality by assessing outputs and providing feedback.
• Understands the scope of work, deliverables, and manages workload as appropriate.
• May give guidance to colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May conduct and present regulatory training sessions for small groups or individuals within the RI team.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Proven experience and tenures working in managing clinical trial applications within Life Sciences (within regulatory authority, consultancy, or industry) in the APAC region and EU region.
• Preferred hands-on experience in clinical trial submissions in the APAC Region and EU region.
• Degree in life sciences and supplementary education with a clinical trials component would be an advantage.
• In-depth knowledge of clinical trial regulations including:
  • Requirements in all phases of drug development (phase I-IV studies)
  • Clinical trial applications to regulatory agencies and ethics committees
  • Regulatory processes and approval times
  • Clinical trial registries and results disclosure
• Ability to assess impact of new regulatory requirements.
• Ability to understand and interpret regulatory developments (guidelines, regulations, and laws) to understand, anticipate, interpret, and communicate regulatory trends and requirements.
• At least 3-4 years relevant experience.
• Ability to communicate clearly and effectively (verbally and written) and experience in writing summaries/reports for different audiences.
• Strong attention to detail, proactive and highly organised.
• Knowledge of quality management within Life Sciences.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
• Demonstrates self-motivation and enthusiasm.
• Ability to work on several projects, with direction from senior staff as appropriate.
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.

Ability to adapt quickly to a rapidly changing environment. 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level

Mid Level