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Clinical Project Specialist

4 weeks ago

Burton upon Trent, Staffordshire, United Kingdom Clinigen Full time
{"h1":{"text":"Medical Information Specialist (MIS) Role at Clinigen"}},

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently seeking a Medical Information Specialist (MIS) to join our team on an initial 12-month fixed-term contract. This exciting role is ideal for individuals with previous experience working in a busy pharmaceutical medical information (MI) team or department, looking to further their career by assisting in the growth and overall management of a highly skilled MI team.

Key Responsibilities:
  • \t
  • Develop an in-depth understanding of Clinigen products, disease areas, and the self-regulatory framework the pharmaceutical industry works within. \t
  • Manage MI enquiries in a timely manner for Clinigen products and MI enquiries for other Pharmaceutical Client products, where Clinigen is contracted to provide MI support, ensuring all pertinent regulations and processes are adhered to. \t
  • Ensure all patient safety issues and product quality complaints are escalated appropriately and in line with standard operating procedures. \t
  • Perform reconciliation activities of received medical Information enquiries, product complaints, and adverse events with other internal and/or external stakeholders as required. \t
  • Perform literature searches to support medical Information activities. \t
  • Review and approve in a timely manner agreed materials and activities within area(s) of defined MI accountability. \t
  • Stay up to date with EFPIA and UK ABPI Code of Practice and share best practice with product and medical teams. \t
  • Review of promotional materials ensuring that scientific and medical data are quoted accurately, that references are appropriate, current, and accurately cited. \t
  • Contribute to quality-related activities including change control management, CAPA (Corrective and Preventative Action), and deviation management. \t
  • Represent medical information in internal and external audits and inspections, as required. \t
  • Assist in maintaining, improving, and promoting the Medical Information service through management of projects and training of or liaison with other groups or customers. \t
  • Represent medical information at external meetings, as required. \
Requirements:
  • \t
  • Demonstrable experience in Medical Information in the Pharmaceutical Industry with an awareness of the ABPI Code of Practice. \t
  • Excellent communication skills – both written and verbal. \t
  • Evidence of effective team working and time management. \t
  • Patient and customer insight through experience in the pharmaceutical industry. \t
  • Problem-solving skills and the ability to think strategically. \t
  • Attention to detail working in a fast-paced environment and a strong communicator. \t
  • Previous experience working in an MI service provider preferable. \t
  • Qualified up to BSc or equivalent life science degree and preferably a UK Registered Pharmacist. \
Benefits:
  • \t
  • 27 days holiday plus 8 bank holidays. \t
  • Pension contributions 4.5% matched. \t
  • Life assurance 4 x annual salary. \t
  • Flexible Benefits Platform with £25/month Company contribution. \t
  • Annual salary review. \t
  • Independent financial advice service. \t
  • Enhanced Employee Assistance Programme. \t
  • Shopping discounts with retailers. \t
  • Long service awards. \t
  • Recognition scheme & employee of the year awards. \

Are you interested in this exciting opportunity?