Senior Medical Advisor Job in Cambridgeshire

Hendre Moolman at CK Clinical is currently recruiting for a Senior Medical Advisor to be based in Cambridgeshire. This position is with a company in the pharmaceutical sector who specialise in pharmacovigilance, medical monitoring and regulatory affairs.

The role:

As Senior Medical Advisor you will be required to review and advise on serious adverse events and non-serious adverse events arising in both clinical studies and the post marketing environment.

Responsibilities:

  • Provide medical input to the Regulatory and Pharmacovigilance departments including generating appropriate sections of regulatory and other documents
  • Provide medical monitoring services for client’s clinical studies, including assessment and granting of waivers, reviewing inclusion and exclusion criteria and reviewing of laboratory and other data
  • Review and advise on serious adverse events and non-serious adverse events arising in both clinical studies and the post marketing environment
  • Liaise with medical departments in client companies and attend project meetings if required.
  • Liaise with external regulatory authorities as required
  • Provide review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling for medical accuracy
  • Assist the Chairman and other project staff in writing bids, contracts and other project related documents
  • Assist in the preparation of Standard Operating Procedures (SOPs)
  • Provide medical information if required by clients
  • Participate in training as required both for internal staff and at Investigator or client meetings
  • Mentor medical advisers and support their training and development.
  • Contribute to and supervise the production of client documents and reports, including protocols and relevant sections of Clinical Study Reports
  • Provide medical review of protocols and study reports for clients
  • Provide medical review of and input to Standard Operating Procedures
  • Support the Pharmacovigilance group in the production of Regulatory
  • Authority and Ethics Committee documentation
  • Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives

 

The ideal candidate:

To be considered for this Senior Medical Advisor position you will have the following qualifications, experience and skills:

  • Medically qualified, with a qualification recognised in the European Union
  • A minimum of 5 years experience in a related field, preferably in the pharmaceutical industry or a CRO
  • Ideally a higher qualification, preferably in Pharmaceutical Medicine
  • Sound analytical skills
  • Effective oral and written communication skills
  • Management experience
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of relevant software, MS Word, MS Excel
  • Good English language and grammar skills

 

How to apply:

For more information or to apply for this Senior Medical Advisor role, please contact Hendre Moolman at CK Clinical on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL23089 in all correspondence.

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