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.
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.
- 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 firstname.lastname@example.org. Please quote reference CL23089 in all correspondence.