Principle Consultant

2 months ago

united kingdom IMC Full time
IMC are currently supporting a UK head quartered client to hire a technical Clinical Development expert to join their fast-growing team. The company Support Global Pharma & Biotech clients with Product Development & Regulatory services. Their international team offers strategic and operational support in the fields of Non-Clinical/Toxicology, CMC, Clinical/Medical and Regulatory.
You will be a technical Clinical Strategy expert joining the team on a full-time basis as a Principal Consultant (Senior Manager / Director / VP of Reg / Head of Department equivalent). The position requires that you have established experience in working independently and leading technical discussions on a range of clinical development topics in compliance with current regulatory requirements. You will be competent in direct hands-on clinical writing and review of documents for regulatory submissions.
This is an excellent opportunity to progress your career at a growing global Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.
Provide strategic, technical, and regulatory advice/services to clients in clinical development of human medicinal products, across a wide range of therapeutic indications & activities
Provide innovative drug development plans, data gap analysis and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment
Support company Business Development activities including:
Sales/marketing introductions
Preparation of project proposals & educational materials
Review written estimates & quotations for accuracy
Contribute to technical authorship and review of development regulatory documents, focusing on FDA, EMA & MHRA activities
Provide technical leadership to other members of the consultancy team, including other Principal and Senior Consultants
Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections
Ensure delivery of project goals within agreed timelines and project budgets
Identify and generate additional business opportunities from current Clients through exceeding expectations relating to the quality, delivery time and cost of services
Educate clients on current regulatory trends and expectations
Establish and maintain a high level of technical knowledge in product development and international regulatory affairs
Challenge the regulatory boundaries from a technical and scientific standpoint
Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities
Provide strategic input/support to company Directors and the company's growth plan
Line manage individual contributors, and in doing so, provide ongoing coaching, mentoring and companywide training (when required)
The role will be affiliated to their UK office
The role will be flexible, working from home with a minimum of one office-based day per month
The selected candidate will report directly to the Head of Clinical
Skills and Experience
A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD)
At least fifteen years of drug development experience, with at least five years in biotechnology and regulatory affairs
Clinical development experience across a range of therapeutic indications/disease areas
Preference for candidates with significant experience in drug development covering Europe, UK, and the United States
Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues
Preference for candidates who have direct experience in providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation
Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK and US authorities.
Proven ability to deliver education via scientific conference presentations in chosen field and training of subordinates
A professional manner and presentable appearance for meeting customers/clients
Ability to work in a proactive and autonomous manner as well as leading a global team, to ensure high-quality of deliverables
Ability to balance competing priorities and complete work within a set timeframe
Exemplary organisational skills with a high level of attention to detail
Exemplary verbal communication and presentation skills in English
High level of computer literacy and competency in MS Office programs
Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally.
Salary & Benefits Include
A Competitive Salary
Company Bonus Scheme
26 Days Holiday Plus additional days for Birthday & Work Anniversary & all UK public holidays
5% employer pension contribution
Private Healthcare
Employee Assistance Programme
Employee Ownership Trust Scheme

  • -Principle Weights Engineer

    2 hours ago

    United Kingdom Synergize Consulting Full time €61,000

    Principal Weights Engineer – U.K Based sites and some travel to the Cumbrian HQ – up to £61k + Benefits A leading Defence client with multiple sites around the U.K are looking to onboard a security cleared or security clearable Principle level Weights Engineer to join the team. We are looking specifically for Weights Engineers that are chartered and...

  • Principle Recruitment Consultant

    2 hours ago

    United Kingdom Demand Talent Full time

    Are you a 360 technical or construction recruiter in Manchester area who wants to earn big commissions, have hybrid working and work alongside a team who have already won lots of PSLs and clients up and down the UK? We're looking for an experienced 360 engineering/technical, civils or construction recruiter or recruitment manager in the ...

  • Pension Consultant

    2 hours ago

    United Kingdom Waterman Aspen Full time

    Flood Risk Consultant Waterman Aspen welcomes engineers and technical specialists to make their mark by working on some of the biggest infrastructure projects or in delivering professional services across the UK on a secondment basis. Our diverse client base includes local authorities, consultancies, public bodies and construction companies. This is...

  • Senior Consultant

    2 hours ago

    United Kingdom Kinect Recruitment Full time €40,000 - €50,000

    Senior Drainage Consultant Location: Job Type: Full-time, Permanent – Monday to Friday We're partnering with a prominent environmental consultancy known for its expertise in flood risk management, drainage solutions, and contaminated land assessments. They’re expanding their team to meet the growing demand in the property sector and are looking for...

  • Training & Consultancy Coordinator

    4 months ago

    United Kingdom Nicholson Glover Full time

    Job Title: Training Manager- Behavioural Science ** **Company:** Behavioural Science Consultancy This leading behavioural science consultancy specialises in designing and delivering cutting-edge training packages to allow their corporate clients to start embedding behavioural science within their teams through various curriculum tailored to a range of...

  • Asap consultant

    1 hour ago

    United Kingdom Next Ventures Full time

    We are partnered with a global brand that is searching for a Windows Automation Consultant. They specialize in building bespoke IT solutions for clients across multiple industries. They are embarking on a new project with a key partner and they are seeking a Windows Automation DevOps Consultant to work on the design, development of the infrastructure...

  • Technical Consultant

    2 weeks ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future.Role Description:The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as a...

  • Technical Consultant

    17 hours ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future. Role Description: The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as a...

  • Technical Consultant

    2 weeks ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future.Role Description:The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as a...

  • Technical Consultant

    21 hours ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future. Role Description: The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as...

  • Technical Consultant

    2 weeks ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future. Role Description: The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as...

  • Technical consultant

    21 hours ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future. The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as a part of a larger...

  • Technical consultant

    2 weeks ago

    United Kingdom Loftware Full time

    A career at Loftware is more than just a job – it’s an opportunity to help shape the supply chain of the future. The Technical Consultant is responsible for a variety of roles in Service Delivery including solution design, technical implementation, application / business rules configuration, deployment, training and documentation as a part of a larger...

  • Sales Consultant

    2 weeks ago

    United Kingdom Lex Leisure Full time

    Company OverviewLex Leisure is a Community Interest Company (CIC) dedicated to enhancing the legacy of significant sporting events, including the Paralympic Games and the Invictus Games. Our mission is to inspire individuals facing physical, mental, or health-related challenges to engage in physical activities.Position SummaryThe role of a Sales Consultant...

  • Senior MarTech Consultant

    2 days ago

    United Kingdom Harnham Full time €75,000

    SENIOR MARTECH CONSULTANT - LONDON UP TO £75,000 THE COMPANY I am supporting a bespoke MarTech Consultancy on a key Senior Consultant hire. THE ROLE The successful Senior MarTech Consultant responsibilities will include: Lead the implementation and configuration of Adobe CDP and Tealium solutions based on client requirements and best practices. ...

  • Oracle Cloud Consultant

    2 weeks ago

    United Kingdom HAAR Recruitment Full time

    The successful candidate will report directly to the Cloud Infrastructure team lead and will be responsible for supporting both the cloud platform, along with third party clouds, including Azure, Oracle and GCP CSP environments. Input into KPI reporting on Billing and Security Metrics Manage and configure Cloud based alerting not covered by proprietary...

  • Flood Risk Consultant

    2 hours ago

    United Kingdom Waterman Aspen Full time

    Job title: Flood Risk Consultant Salary: Dependent on experience, skills and location An introduction to our unique company… Waterman Aspen welcomes engineers and technical specialists to make their mark by working on some of the biggest infrastructure projects or in delivering professional services across the UK on a secondment basis. Our diverse...

  • Cloud Security Consultant

    1 hour ago

    United Kingdom La Fosse Full time

    Cloud Security Consultant A Global Tech company require a Contract Cloud Security Consultant . In this role, you will collaborate with the Enterprise Security, Architecture, Cloud Enablement & Engineering teams to plan, implement, and optimise security controls in the cloud, particularly within multi-cloud environments. Your expertise will be crucial...

  • D365 F&O Consultant/Trainer

    6 hours ago

    United Kingdom Catch Resource Management Full time €500 - €550

    D365 F&O Trainer – Dynamics 365, D365 F&O, Dynamics 365 Finance, D365 Functional Consultant, Dynamics 365 Functional Consultant, Functional Consultant, D365 Trainer, Dynamics 365 Trainer – Hybrid - Warsaw - £500-550 per day Our global End User client require a D365 F&O Trainer to join them for an initial 6 month engagement and provide training to...

  • D365 F&O Consultant/Trainer

    2 weeks ago

    United Kingdom Catch Resource Management Full time €500 - €550

    D365 F&O Trainer – Dynamics 365, D365 F&O, Dynamics 365 Finance, D365 Functional Consultant, Dynamics 365 Functional Consultant, Functional Consultant, D365 Trainer, Dynamics 365 Trainer – Hybrid - Warsaw - £500-550 per day Our global End User client require a D365 F&O Trainer to join them for an initial 6 month engagement and provide training to...