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ICON Clinical Research Consultant - Strategic Regulatory & Safety Affairs in United States

Consultant - Strategic Regulatory & Safety *LI-MB1

Location: Any EU country, Ideally Italy, Spain

ICON plc, a leading Clinical Research Organisation, employing 14,500 people across 97 offices in 38 countries - our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!

We are currently offering a phenomenal opportunity for a consultant with Regulatory Affairs experience. You will be responsible for providing comprehensive regulatory services for clients requiring support for registration and maintenance activities in Europe and Internationally for drugs, biologics and other product types (food, cosmetics, substances). This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients.

The primarily responsibilities of this job include:

  • Effectively prepare regulatory files and provide support for maintenance activities in adherence with applicable legislation and guidelines, facilitating approvals and continued client compliance

  • Manages and ensures maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions

  • Lead/attend formal interactions (face-to-face meetings, teleconferences, etc.) with clients and, possibly, government agencies

  • Develops initial or alternative regulatory strategies consulting with their Manager and other resources within the organization. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.

  • Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met

  • Lead, participate in and support project teams related to regional filings and maintenance activities across a range of product types

  • Effectively prioritize and complete multiple projects within established timeframes

  • Actively monitors for new regulatory requirements and shares key findings

  • This role will be accountable for maintenance of their utilization goal while maintaining an appropriate positive revenue stream. Manage project workflow overseeing progress and completion of projects with team members to facilitate meeting billable percent targets and client deadlines

  • This role will prepare quotations for projects that may cross multiple service areas within the company and manage projects within budget preparing change orders as needed

  • Enthusiastically improve business processes and tools to facilitate provision of core services

  • Ability to travel (10%) as necessary, passport required

Education/Experience:

  • Undergraduate degree preferably in science, nursing or healthcare field or equivalent qualification/experience.

  • Relevant experience in pharmaceutical, biologics, medical device industries

  • Experience in consulting, supporting business development activities and people management an asset.

  • Experience presenting at applicable industry conferences and/or publications in regulatory affairs considered advantageous.

  • Certification in regulatory affairs (RAC; EU, US, Canada) or post-secondary institution beneficial

Knowledge/Skills/Attributes:

  • Strong working knowledge of relevant local Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines and medical device guidances.

  • Ability to maintain a high level of accuracy and attention to detail.

  • Ability to work relatively independently.

  • Ability to exercise sound judgment and make decisions independently.

  • Excellent planning, organization, interpersonal, time and change management skills.

  • Effective project management skills.

  • Knowledge of business development process.

  • Demonstrated good problem solving, judgment and decision-making skills with the ability to motivate staff to seek creative solutions to issues surrounding on-time, on-budget and quality consulting deliverables.

  • Sound listening, conflict management and negotiation skills.

  • Highly self-motivated and proactive.

  • Proven ability to motivate, mentor and coach others.

  • Problem solving skills balanced with awareness of business objectives

  • Good judgment in the face of difficult and unclear situations.

  • Communication, verbal & written - Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding.

  • Attention to detail – Identifies and resolves discrepancies across various source documents including published and unpublished documents. Notes and resolves errors in written documentation

  • Planning & organizing – Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Has a routine or system for completing work. Consistently meets timelines and works within budget.

  • Problem solving & decision-making – Demonstrates ability to make sound decisions. Focuses on resolving problems and makes decisions in a timely manner. Promptly notifies staff/team of any problems and any decisions made.

  • Proven ability to understand and communicate corporate policies and procedures.

  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint.

Education/Experience:

  • Undergraduate degree preferably in science, nursing or healthcare field or equivalent qualification/experience.

  • Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.

  • Relevant experience in pharmaceutical, biologics, medical device industries

  • Experience in consulting, supporting business development activities and people management an asset

  • Certification in regulatory affairs (RAC) or post-secondary institution beneficial

  • Experience presenting at applicable industry conferences and/or publications in regulatory affairs considered advantageous.

Benefits of working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a phenomenal career.

We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. Other than working with a phenomenal team of switched on and ambitious people, we also offer a very competitive benefits package.

This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

ICON is an equal opportunity employer Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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