Organisation

Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world.  The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines.  Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

We are currently 800+ people, headquartered in the UK, with global offices in the US, Australia, New Zealand, Japan, South Africa, Singapore, Hong Kong and Athens.  Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth we’re always on the lookout for highly motivated, ambitious and committed individuals to join our highly successful team.

Role

The role is responsible for providing medical information and medical communications support across all divisions of the Clinigen Group.

The key responsibilities for this role are:

Leadership

  • Implementation of a centralised medical information function to support the Clinigen Group
  • Leadership of the Medical Information function
  • Provide advice and support across the company in regards to Medical Communications particularly in support of divisional strategic business plans
  • Recruitment and management and development of the Medical Information team in line with business requirements

Vendor Management

  • Management of Medical Information vendor supporting Specialty Products (SP)
  • Main point of contact for Medical Information vendor for all escalated enquiries
  • Management of Translation Services vendor
  • Track vendor deliverables and expenditure against budget
  • Management of tasks delegated  to vendors, in line with agreed deadlines
  • Guidance and training of vendor staff, as required
  • Support the Quality Assurance team at vendor audit
  • Assessment of vendor’s performance against agreed KPIs

Operational responsibilities

  • Oversee and review as necessary medical enquiries managed by Medical Information vendor relating to Clinigen’s SP products
  • Management of escalated medical enquiries for Clinigen-owned products
  • Development, with the support of the Regulatory function and the Medical affairs director as necessary, and maintenance of standard responses for Clinigen’s SP products
  • Ensure the provision of an effective MI service by the in-house  medical information team for Clinical Trial Supplies, Managed Access and Global Access divisions as per agreed internal KPIs
  • Ensure the Medical Information systems and processes at Clinigen are aligned with corporate strategy and pertinent legislation
  • Participation in regulatory inspections as required
  • Management of changes to IT platform
  • Ensure SOP’s are updated regularly to meet the operational and regulatory requirements

Business Development

  • Liaison with distribution partners, customers, clients and other business partners regarding medical information procedures, agreements and services
  • Provide training to relevant departments in the products and activities supported by the Medical Information function, and to external bodies as appropriate to the development of the business
  • Participate in appropriate business development and stakeholder engagement activities to ensure Medical Information services are understood by key stakeholders and the service is developed to differentiate Clinigen from its competitors
  • Design and implement cost effective and efficient medical information solutions to support all four business divisions as required
  • Tender support
  • Due diligence support, if necessary, for new product acquisition

Personal Development

  • Maintain a working knowledge of all of the businesses in the Clinigen Group
  • Keep up to date with and follow all relevant Standard Operating Procedures, Regulatory, Legal and Ethical requirements in support of medical information and medical communications
  • Continued professional development pertinent to the role

Application

If this role is of interest to you please send a recent copy of your CV to recruitment@clinigengroup.com and a member of the Talent Acquisition team will be in touch.