Career Opportunities

TMC Pharma Services is looking to add the following full-time roles to our friendly and professional team

Regulatory Executive/Director

TMC Pharma Services is a unique niche pharmaceutical development organisation based in the UK with worldwide capability. Our clients include all types of pharma companies, from large multinationals to small innovative biotechs/virtual organisations.

After another very successful year, we are again expanding our regulatory team and are therefore looking for a self-motivated regulatory affairs professional who enjoys working on a variety of projects and in a fast paced, innovative environment.

You should have hands-on experience of some or all of the following:

  • Clinical Trial Applications
  • Scientific Advice procedures
  • Orphan Drug Designations
  • Paediatric Investigation Plans
  • ATIMPs
  • EU/Rest of World Marketing Authorisation Applications
  • Post authorisation submissions (variations, renewals, etc.)

The ideal candidate will have a scientific degree (or equivalent), strong project management and team working skills, and a flexible attitude to the types of projects they work on. Experience in a service organisation is also desirable. For a senior role, the candidate ideally should also be able to demonstrate leadership skills and have a proven track record in providing strategic regulatory advice.

To apply, please send your CV to nicola.kidman@tmcpharma.com .

Director/Associate Director, Clinical Project Management

Functional Area: Clinical Development
Based: TMC Office, Fleet, UK, global travel as required
Package: Excellent Salary and benefits package

The Company

Established in 2001, TMC Pharma Services Ltd (www.tmcpharma.com) is a successful, independent, European specialty pharmaceutical services company. TMC’s reach is global and its range of services is broader than even the largest service organisations. TMC’s head office is based in Hartley Wintney, near Fleet in Hampshire, where a core team of senior personnel manage a network of over 300 Associates located around the World that provide unparalleled expert services to Pharma and Biotech clients.

TMC’s focus is to provide support to, and partnership with, smaller companies throughout a development programme; and beyond if required. We have particular and significant expertise in the development of niche and innovative products.

Job Summary

Leadership of cross­functional matrix programme teams (including Clinical, Medical/PV, Regulatory, Non­clinical and CMC functions) to ensure quality and timely overall operational execution of projects in accordance with our clients’ needs.

Responsibilities

  • Development of overall project plans and project budgets for approval by Clients. Communication of all aspects of the project plans (schedule, budget, resource, options, assumptions and risks) throughout a project, ensuring these plans comply with overall Client strategy
  • Continuous team leadership and oversight to drive projects to pre­empt and address issues ensuring completion with high quality, in the right timeframe, at the agreed cost
  • Work with external partners, Associates and Vendors
  • Design, develop and improve project management tools and processes, implement QA/QC activities as required

The Ideal Applicant

A confident, creative problem solver with excellent organisational, communication and presentation skills, who demonstrates leadership and ownership of project deliverables. He/she should:

  • have a first degree in Science/Pharmacy/Engineering/Technology preferably have managed clinical sites/studies and have completed some formal training in Project Management
  • have experience of global project or programme management, ideally with projects covering all development phases from pre­clinical to full development and registration

To apply for this position please submit your full CV and covering letter to Sarah Blondell, Senior Director of Clinical Services, TMC Pharma Services, sarah.blondell@tmcpharma.com

We are always seeking highly experienced, freelance associates, across the globe in the following areas;

  • Regulatory affairs
  • Clinical Monitoring
  • Clinical Project Management
  • Subject Matter Experts; CMC, Non-clinical, Clinical