Scientific Affairs Advisor - Final Medical Signatory

Job Role:

• Provide a comprehensive medical information service to internal and external customers and to support improvements and maintenance of medical information systems.
• Manage out of hours calls and the out of hours service provider contract.
• Works closely with other SAAs to help provide scientific advisory support for claims/materials development and approval, ensuring compliance with the relevant Codes of Practice and legislation.
• Act as an experienced key member within the cross-functional disease team, working closely with Medical Affairs, Marketing, Market Access and Regulatory, maintaining high levels of Code compliance whilst supporting commercial and medical aims and activities.

Role and Responsibilities:

• Acts as final medical signatory for the Portfolio team.
• Works cross-functionally and collaboratively to develop compliant solutions for various different projects and is seen as an expert on the ABPI/IPHA codes of practice
• Develops a good working knowledge of company Standard Operating Procedures (SOP) with the aim of being able to advise on compliance issues and certify materials (As required)
• Provide scientific advisory support for claims/ materials development, ensuring medical accuracy of scientific content, and compliance with relevant Codes of Practice and legislation.
• Responsible for data provision and ensuring data maximises commercial potential
• Actively involved in the development and implementation of operational plans including disease team and medical plans, and also takes the lead on specific tactical objectives and deliverables
• Supporting Medical Affairs and the Marketing team to develop market leads for developing and driving the disease team plan and leveraging clinical scientific data to optimise the adoption of the promotional campaigns
• Prepare and deliver brand-related presentations and training to field teams as required
• Act as final medical signatory for a variety of meetings to support the disease team as required, including commercial meetings congress support and medical meetings.
• Act as a point of escalation for medical information queries
• Support and manage the third-party service provider including management of contracts, working practices and regular quality control checks to ensure compliance with relevant procedures and legislation
• Formulate high quality written and telephone responses reflecting the most recently available data on company products in response to enquiries received from both internal and external customers and ensure responses conform to both company guidelines and practices and the ABPI code of practice
• Develop and maintain Medical Information standard responses for use in The UK and Republic of Ireland in collaboration with Global Medical Information
• Perform weekly quality checks (QC) checks on medical information responses, liaising with US colleagues to ensure global consistency and provide reports for all safety enquiries received via Medical Information, to the drug safety team for reconciliation
• Ensure adverse events and pregnancy reports are duly processed in line with company procedures and assist in assessment of adverse event reports originating in the UK and Ireland for completeness, consistency and reporting requirements
• Manage the companys Copyright licences. Liaison with the Copyright Licensing Agency to ensure all clinical papers distributed or received are within copyright laws and our licence
• Responsible for the development/maintenance of relevant SOPs, in collaboration with the Medical Director and Regulatory, Quality and Compliance team.

Education, Skills and Experience:

• Registered medical practitioner or pharmacist registered in the UK
• Essential to have past Pharmaceutical Industry experience for at least three years and preferably prior experience in the provision of Medical Information service
• Final medical signatory with excellent knowledge of the ABPI Code of Practice
• Past experience in Haematology/Oncology therapy area desirable
• Literature database searching and related computer skills
• Clinical data interpretation skills
• Medical writing skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Green on +44 203 814 1317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.