Career Opportunities

Work for us

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

Pharmacovigilance Officer

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 Pharmacovigilance Officer 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?

Working in the Pharmacovigilance Department alongside in-house Pharmaceutical Physicians and PV Associates, you will primarily be responsible for:

  • Delivering assigned projects, ensuring consistent high-quality deliverables on time and to budget, while fulfilling client needs and maintaining engaged project teams, both in clinical trials and with marketed products
  • liaising with other PV professionals who work with TMC
  • supporting the maintenance of the PV System Master File
  • supporting the management and improvement of TMC’s internal PV processes
  • contributing to both single case processing and the preparation of periodic reports

Who Are You?

  • Relevant degree in a Life Science discipline or equivalent, or a recognized nursing qualification
  • 1+ years’ experience in Pharmacovigilance in the Pharmaceutical Industry
  • Basic knowledge of GVP legislation
  • Experience of case handling/processing/submission for both clinical trials and marketed products within a safety database

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

Junior Pharmacovigilance Officer

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 Junior Pharmacovigilance Officer 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 Junior Pharmacovigilance Officer will:

  • assume overall responsibility for the receipt, triage and processing of cases, ensuring consistent delivery of high-quality deliverables
  • maintain SAE/AE trackers
  • triage SAEs (including AESIs) & ICSR (ADRs) reports received
  • enter relevant case information into the safety database
  • clarify data reported in the Serious Adverse Event and Adverse Drug Reaction reports
  • request medical review of cases as required
  • code Adverse Events and the medicines/treatments recorded on the Adverse Drug Reaction and Serious Adverse Event reports
  • participate in TMC project team meetings
  • support PV Inspection activities
  • support other PV activities e.g., individual case management and processing

Who Are You?

Essential:

  • A nursing or pharmacy qualification or life science qualification with some work experience in a clinical environment
  • Able to understand medical terminology

Desirable:

  • Experience working with databases and spreadsheets
  • Pharmacovigilance experience

Please send an application letter and CV to info@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.