- Project Manager- Pharmaceutical
- Exciting, growing Pharmaceutical service organisation
- West London (good public transport links)
- £40,000 plus a competitive bonus, pension and healthcare structure in place
- Knowledge of ICH GCP regulations ESSENTIAL
- Strong project management skills ESSENTIAL
Summary
Alex Dobson is recruiting for an exciting opportunity that is ideal for a bright and ambitious Project Manager with a background in Clinical Trials, to work with a leading Expanded Access and Name Patient Programme organisation. For this position you will be the primary point of contact for clients, managing all aspects of the delivery of the project as well as providing advice and guidance. If you have strong knowledge of ICH GCP and excellent project management skills which can be applied within a clinical trial services organisation, this will be an excellent chance to develop your organisation within a growing company.
The Company
A young, ambitious, SME pharmaceutical service company based in West London. As an organisation they focus on providing patients with untreated medical needs who have tried all the available treatment options. They offer EAP options that can help life-threatening illnesses, allowing them to look at new treatment options. In addition to this they offer a programme which gives access to unlicensed or unavailable medicines to patients around the world. They are looking to expand their middle management team and have a role for an exceptional candidate with a background in GCP and co-ordinating with the Responsible Person.
The Role
As a Project Manager you will be accountable for the setup, implementation and delivery of Expanded Access Programs for Pharmaceutical and Biotech Companies. You will be the primary point of contact for clients, managing all aspects of the delivery of the project as well as providing advice and guidance. This is a pivotal role and requires a strong customer focus and attention to detail as well as the ability to develop and execute project plans, track against KPIs, identify risk and contingency planning.
Key accountabilities/responsibilities will include the following:
- Working with Sponsor and internal teams to implement and execute devised project plans.
- Researching and understanding new territories by country regulations for project implementation.
- Order Management, process design and implementation.
- Logistics & stock management - liaising with couriers & external partners.
- SOP management and review (with support from Quality function).
- Country specific regulatory submissions.
- Handling queries and management of issues.
- Management of shipping documents, customs queries.
- Order processing.
- Client first port of call for project status and updates.
Experience
As a Project Manager, you will have the following qualifications, skills and experience:
- Educated to degree level within Life Sciences (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification / experience.
- Experience managing multiple projects with different customers.
- Account management / service sector background preferred.
- Strong interpersonal skills and ability to motive members with in a matrix system.
- Strong knowledge of ICH, GCP, and the UK clinical trials environment/ drug development process.
- 2nd language (other than English) is advantageous.
- Previous experience in a project management role, with projects requiring specific deliverables of logistics, external & internal communication plans, supply chain, regulatory (ideal) and KPI measures.
- Excellent planning and organizational skills.
- Ability to communicate at all levels.
Keywords
Pharmacy, Pharmaceutical, Biotech, Life Sciences, Project Manager, Clinical Trial, Expanded Access, Compassionate Use, Clients, ICH, GCP, SOP, Drug Development West London, Chiswick, Brentford, Acton, Middlesex.
This is a permanent position