Career Opportunities

Work for us

Clinical Trial Administrator (CTA)

The Company

TMC Pharma is a unique Pharmaceutical Development Organisation combining traditional CRO services with full support for all product development activities in the pre-, peri- and post-marketing phases.

We have an opportunity for a Regulatory Director/Associate Director with hands-on operational experience to join our team. This is a full-time, office-based role in our UK Head Office at Hartley Wintney in Hampshire.

What Will You Do?

The role of the Clinical Trial Administrator (CTA) is to support the Clinical Project Management team to ensure the smooth running of the clinical project, through expert knowledge and effective use of the systems, tools and processes available.

Responsibilities will include:

  • Maintenance of the Trial Master File (TMF)
  • Study Tracking
  • Project support to PM and CRA team
  • Support continual improvement to enhance effectiveness of CTA role

Who Are You?

Specification (education, experience, other characteristics):

  • Degree-level qualification (desirable)
  • 2+ years’ experience in a CTA role (or equivalent)
  • Knowledge of GCP and relevant local legislation, including current GCP certificate
  • Expert knowledge of Electronic TMF
  • Exceptional interpersonal skills
  • First-class administrative and organisational skills
  • Proactive approach to work, demonstrating initiative and reliability

Please send an application letter and CV to laura.nuttall@tmcpharma.com

Regulatory Director / Associate Director

The Company

TMC Pharma is a unique Pharmaceutical Development Organisation combining traditional CRO services with full support for all product development activities in the pre-, peri- and post-marketing phases.

We have an opportunity for a Regulatory Director/Associate Director with hands-on operational experience to join our team. This is a full-time, office-based role in our UK Head Office at Hartley Wintney in Hampshire.

What Will You Do?

The successful candidate will join a regulatory team of 5 and will be able to act as the lead on global regulatory projects; coordinating, preparing, reviewing and submitting regulatory submissions in compliance with the applicable SOPs, regulatory guidelines and legislation.

This is a senior hands-on role that will suit a self-motivated Regulatory professional who enjoys working in a client facing role on a broad spectrum of projects including challenging programmes and rare diseases. No two projects are the same, however the ideal candidate will have prior experience of the following:

  • Developing global regulatory strategy
  • Agency meetings (Scientific Advice, Protocol Assistance, pre-IND and FDA meetings)
  • Orphan Drug Designations in the US, EU and Japan
  • Paediatric Investigation Plans
  • EU/Rest of World Marketing Authorisation Applications
  • Post Authorisation Submissions
  • Global clinical trial applications and maintenance
  • Client management including provision of high-quality deliverables on time, on budget, while fulfilling client needs and maintaining engaged project teams
  • Business development, including writing proposals, creating project budgets and attending bid defence meetings

Who Are You?

Specification (education, experience, other characteristics):

  • A life science degree (or equivalent)
  • A can-do attitude! Ability to work under own initiative, comfortable to run and lead projects and to be client-facing
  • pro-active attitude and pragmatic approach to deliver objectives
  • excellent organisational, interpersonal and communication skills
  • able to undertake some international travel depending on project needs
  • A good sense of humour and a love of dogs is essential!
  • Strong software and computer skills, including MS office applications
  • Eligibility to work full-time in the UK

Please send an application letter and CV to nicola.kidman@tmcpharma.com

Medical Director / Associate Director

The Company

TMC Pharma is a unique Pharmaceutical Development Organisation combining traditional CRO services with full support for all product development activities in the pre-, peri- and post-marketing phases.

We have an opportunity for a Medical Director/Associate Director with hands-on operational experience to join our team. This is a full-time, office-based role in our UK Head Office at Hartley Wintney in Hampshire.

What Will You Do?

The successful candidate will:

  • lead delivery of medical aspects of TMC projects (clinical trials, regulatory submissions, pharmacovigilance, medical writing, etc) to:
    • provide advice on clinical development plans
    • perform the hands-on Medical Monitor role (and manage regional Medical Monitors in global studies, as required); to oversee medical aspects and facilitate the conduct of clinical studies
    • provide medical expertise and support for preparation of key study documentation (including, but not limited to, the protocol, IB, ICF, eCRF, SAP, CSR, etc.)
    • review and facilitate the interpretation of clinical and safety data
    • provide out of hours medical support, as required
    • provide training and mentorship to both TMC and client personnel, as required
  • work in partnership to support all pre-, peri-, and post-marketing TMC Pharmacovigilance activities
  • cooperate closely with TMC’s Regulatory department to provide medical input to TMC’s regulatory activities (e.g. MAA, ODD, Scientific advice, etc.)
  • support and deputise for the Head of Medical Services
  • establish and maintain professional relationships between TMC and external medical experts and KOLs; represent TMC at Investigators’ meetings and expert panels
  • support delivery of medical writing projects

Who Are You?

Specification (education, experience, other characteristics):

  • qualified physician (medical degree)
  • at least 3 years of Pharma industry experience ideally encompassing more than one aspect of pharmaceutical medicine, e.g. R&D, PV and medical affairs
  • Dip.Pharm.Med desirable
  • some experience of clinical practice in a relevant specialty (e.g. rare diseases, immunology, oncology) would also be desirable
  • pro-active attitude and pragmatic approach to deliver objectives
  • excellent organisational, interpersonal and communication skills
  • able to undertake some international travel depending on project needs

Please send an application letter and CV to tomasz.knurowski@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

If you feel your skills and experience are right for TMC, we'd be pleased to hear from you.