Full time role, starting asap.
We are a specialist provider to the healthcare industry for both Clinical Research and Regulatory Affairs projects – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed and all their requirements are exceeded.
We are looking for a senior Regulatory professional to join our European team, to be based in Marlow to lead a variety of projects.
Your daily workload will be fluid and completely responsive to our clients’ requests – and no project is the same. We need someone who is an excellent communicator, a selfless team player, a brilliant multitasker – but most of all, someone who has a good sense of humour! We want to enjoy our work, have a happy office and consistently deliver exceptional services to our customers – so we are only recruiting people with a can-do, why-not, positive attitude.
Role Description: Senior Regulatory Affairs Project Manager, Marlow Bucks
The ideal candidate will have:
10+ years broad regulatory experience, ideally spanning pharmaceuticals, consumer healthcare, biotechnology and animal health products. Our projects are diverse – so we are looking for someone who can turn their hand to anything!
Extensive experience of European and MENA regulatory affairs including regulatory strategy, in-depth knowledge of CMC, dossier builds and post-approval maintenance work. Ideally experience of all European procedures (MRP, CP, DCP) as well as direct contact with the Health Authorities. You will represent G&L to our clients and the agencies – so interpersonal skills are paramount.
Experience of management large teams – acting as mentor to junior staff, developing individual training programmes. Our company is all about our people – so you should have a passion for meritocracy, recognition and development.
Experience of working in client-facing environment, experience of designing, running and executing bespoke client projects. Experience of managing projects, including resource management, budgeting, timelines and deliverables.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
The Clinical Supplies Manager (CSM) has demonstrated experience in performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The CSM is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.
Role Description: Clinical Supplies Manager
Clinical Supplies Project Manager will consult with client, CRO, Packager, Logistics and IRT as necessary to lead or assist the following as required:
Education or Equivalent:
- Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
- Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs
- Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies
- Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrolment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
- Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
- Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites
- Workswith IRT in creation of system specifications (URS) associated with supply algorithms
- Act as Unblinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study x Monitor and oversee Warehouse and Depot drug levels within IRT throughout study.
- Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life
- Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study x Assist in the provision of budget estimates in support of quotations for clients
- Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable
- May provide support of training of other Project Managers in aspects of clinical supply management
- May provide input in development / improvement of existing business processes and contribute to the revision or development of associated training materials
- May participate in Business Development activities to grow the business
- Bachelor's degree in a science, supply chain or related discipline
- 6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle.
- Experience in supply tracking requirements and systems
- Experience in the use of forecasting tools.
- Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
- Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR),
- Working knowledge of global supply labelling requirements
- Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
- Strong knowledge in IRT technology as it relates to supply chain management
- Skilled in client relationship management and ability to influence customer demand x Excellent interpersonal skills and problem solving/decision making skills
- Extensive experience of using MS Office programs, with a particular aptitude for MS project and Excel.
- Strong communication skills both written and verbal